Jump to content

Information Resources

edriscoll
A new study is open for people over 18 who have developed POTS after having a COVID infection.  The clinical trial is to learn more about a new medication that may decrease POTS symptoms by decreasing autoantibodies.  
To learn more about this study and to see if you qualify, visit:
https://www.alphastudyforpots.com/#!/
edriscoll
Published in Immunologic Research, April 2021
Study conducted by Dr. Svetlana Blitshteyn and Sera Whitelaw
Full article available: https://link.springer.com/article/10.1007/s12026-021-09185-5#Abs1
Objective:  To describe clinical features, diagnostic findings, treatments, and outcomes in patients with new-onset postural orthostatic tachycardia syndrome (POTS) and other autonomic disorders following SARS-CoV-2 infection (COVID-19).
Methods:  We retrospectively reviewed medical records for patients who presented with persistent neurologic and cardiovascular complaints between April and December 2020 following COVID-19 infection.
edriscoll
Published December 2022, Nature Cardiovascular Research
Full article:  https://www.nature.com/articles/s44161-022-00180-z
Introduction: Postural orthostatic tachycardia syndrome (POTS) can follow COVID-19 as part of the post-acute sequelae of SARS-CoV-2 infection, but it can also develop after COVID-19 vaccination. A new study shows that the rate of new-onset POTS diagnoses is slightly increased after COVID-19 vaccination, but is five times lower than the rate of POTS diagnoses after SARS-CoV-2 infection.  
Contributors:  Svetlana Blitshteyn & Artur Fedorowski 
 
edriscoll
Published December 2022, Nature Cardiovascular Research
Full article available: https://www.nature.com/articles/s44161-022-00177-8
ABSTRACT:  Postural orthostatic tachycardia syndrome (POTS) was previously described after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection; however, limited data are available on the relation of POTS with Coronavirus Disease 2019 (COVID-19) vaccination. Here we show, in a cohort of 284,592 COVID-19-vaccinated individuals, using a sequence–symmetry analysis, that the odds of POTS are higher 90 days after vaccine exposure than 90 days before exposure; we also show that the odds for POTS are higher than referent conventional primary care diagnoses but lower than the odds of new POTS diagnosis after SARS-CoV-2 infection. Our results identify a possible association between COVID-19 vaccination and incidence of POTS. Notwithstanding the probable low incidence of POTS after COVID-19 vaccination, particularly when compared to SARS-Cov-2 post-infection odds, which were five times higher, our results suggest that further studies are needed to investigate the incidence and etiology of POTS occurring after COVID-19 vaccination.
Contributors:  Alan C. Kwan, Joseph E. Ebinger, Janet Wei, Catherine N. Le, Jillian R. Oft, Rachel Zabner, Debbie Teodorescu, Patrick G. Botting, Jesse Navarrette, David Ouyang, Matthew Driver, Brian Claggett, Brittany N. Weber, Peng-Sheng Chen & Susan Cheng 
edriscoll
by Ellen Driscoll
POTS has been receiving an increase in attention in both the media and the medical field as a result of COVID-19 infections. For many patients, illness continues long after they have come through the COVID infection.  This syndrome is commonly referred to as Long COVID or the patients experiencing this are called "Long Haulers".  For many people, the after effects of illness or the long haul occurs months after the initial infection has resolved. In a recent study by Dr. Svetlana Blitshteyn of the Dysautonomia Clinic, 6 to 8 months after COVID-19 infection, patients developed residual autonomic symptoms debilitating enough to prevent a return to work. (1) What is not known is if a history of mild autonomic dysfunction or other markers that are common triggers for autonomic dysfunction such as concussion may be risk factors for developing post-COVID autonomic disorders. (1) 
In a recent survey published in eClinical Medicine, almost half (43.4%) of their respondents developed at least one post COVID condition, and almost 3/4 (72%) of those patients reported symptoms suggesting POTS as a secondary disorder post infection (2). The symptoms, post illness, continuing for 3 to 6 months as part of the diagnostic criteria.  A Mayo Clinic Study found 80% of long-haulers living with "persistent fatigue" and half living with "brain fog" (5).  The Mayo Clinic's CARP program (COVID-19 Activity Rehabilitation Program) reports 59% of patients with respiratory complaints and one-third of long-haulers reported being unable to perform daily tasks associated with managing day-to-day life (5) The prevalence of POTS was documented in an international survey of 3,762 long-COVID patients, leading researchers to conclude that all COVID patients who have rapid heartbeat, dizziness, brain fog or fatigue “should be screened for POTS.” according to Dr. Peter Rowe, John Hopkins.(8) Another common condition tied to the after effects of COVID-19 is ME (CFS) (2) or Chronic Fatigue Syndrome.  Dr. Rowe has treated both POTS and CFS patients for over 25 years and said every doctor with expertise in POTS is seeing long-haul COVID patients with POTS, and every long-COVID patient he has seen with CFS also had POTS. (8) For physicians, diagnosing these complex conditions can be made more difficult by the fact that ME and POTS can have many over lapping symptoms.  
The treatment for POTS can be complicated given the multisystem effect the disorder has on the body. Research from John Hopkins suggests that it is not only acute COVID infections that are resulting in long lasting symptoms, citing patients with mild COVID illness also reporting signs of possible ANS dysfunction that may suggest POTS.(6)  What is less known is how long these post-COVID illnesses may last.  According to Dr. Svetlana Blitshteyn of the Dysautonomia Clinic, the claim that patients can outgrow POTS is unrealistic.  She says "my go-to answer is we don't know if/when you'll recover, but you'll feel better with the right treatment." (7)
For people living with POTS before becoming infected with COVID-19, POTS symptoms may temporarily worsen (6).  However, there is no evidence to date that there are permanent effects on the ANS or the progression of the disorder.  Treatment for Post COVID POTS is similar to POTS treatment unrelated to COVID. Frequently a pharmacological approach combined with life-style alterations and exercise, as tolerated, gives the patient the most long-lasting benefits.(6) However, in both acute COVID illness and mild illness, physical therapy and/or rehabilitation may be necessary to help with reconditioning due to the multisystem involvement caused by COVID.(6) Each patient should have an individual treatment plan developed and monitored by a physician knowledgeable about POTS and ANS function to be the most effective.
Complicating treatment is that the number of physicians familiar with the diagnosis and treatment of POTS is insufficient for the numbers of new cases of Post COVID POTS (4) Dr. Rowe says he expects the lack of medical treatment to worsen. (8) The waiting lists for specialists in ANS dysfunction can be 6 - 12 months or longer and the multi-disciplinary approach necessary for the treatment of POTS is rarely available in clinics where appointments may be open.  In an American Autonomic Society article addressing these concerns, Dr. Satish Raj and associates comments "These patients have complicated medical conditions that will require longer visits and more allied health care personnel (including nurses, physiotherapists and psychologists) to deliver the needed care. In other words, it will not be possible to address the needs of this population without a commitment not just from the providers, but also hospitals and medical center administration." (4)
Although the mechanism causing Post COVID POTS is unknown, recent findings suggests inflammatory, auto-immune responses and the generation of auto-antibodies  to be at play (3) It is postulated that the cytokine storm from the COVID-19 infection results in sympathetic dysregulation, causing the abnormal autonomic response in POTS (3) Further studies are needed to determine whether post-COVID-19 autonomic disorders are rooted in autoimmunity and what type of antibodies or cytokines may be mediating the autoimmune and/or inflammatory process.(1) Congress has allotted 1.5 billion in funding to the National Institute of Health over the next four years to study post-COVID conditions (4).  The light at the end of the devastation caused by COVID-19 may be the awareness it is bringing to some of the less familiar, yet debilitating illnesses like POTS and CFS into the forefront of the medical community.   
To learn more about COVID-19, watch Dr. Blitshteyn's video
Resources and References
1. Postural Orthostatic Tachycardia Syndrome (POTS) and other autonomic disorders after COVID infection: a case series of 20 patients, Dr. Svetlana Blitshteyn  and Sera Whitelaw
https://link.springer.com/article/10.1007/s12026-021-09185-5
2. Characterizing long-COVID in an international cohort: seven months of symptoms and their impact.
https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(21)00299-6/fulltext#seccesectitle0048
3. Management of Long-COVID and Postural Orthostatic Tachycardia Syndrome with Enhanced External Counterpulsation
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8555928/
4. American Autonomic Society Long COVID-19 and Postural Orthostatic Tachycardia Syndrome: An American Autonomic Society Statement (with Dr. Satish Raj)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7976723/
5. Post-COVID-19 Syndrome (Long Haul Syndrome): Description of a multidisciplinary clinic at Mayo Clinic and characteristics of the initial patient cohort
https://www.mayoclinicproceedings.org/article/S0025-6196(21)00356-6/fulltext
6. COVID-19 and POTS: Is there a link?
https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/covid19-and-pots-is-there-a-link
7. @dysclinic Twitter, S. Blitshetyn MD, Dysautonomia Clinic #longCovid
8. Little known illnesses turning up in COVID long-haulers
https://khn.org/news/article/covid-long-haul-illness-pots-autonomic-disorder/
Goldstec

Patient Guide - Information sheets

By Goldstec, in POTS,

Information sheets to help you prepare for your trip to the ER or to a new medical practice.
The pdfs of these sheets can be downloaded here Patient Guide - medical trips.pdf for easy printing.
Medications - current
Name                    dosage              prescribed by                     to treat what symptom
 
 
 
 
 
 
********************************************************************
NOTES:  allergies and notes about reactions to meds should be detailed here.







Medical History:
Illnesses:  (be sure to include when you had the illness, treatment for the illness and whether you completely recovered or are still being treated for this illness)








 
Surgeries:  (date, what the surgery treated, was it successful or not? If not, what lasting complications, if any)









Specific test ranges or numbers - standard to you.  
HR range:
BP range:




 
Doctor or medical professional most familiar with your illness
Name__________________________________
Email Address______________________________________
Phone__________________________
edriscoll
Fainting or coming close to fainting is one of the very common symptoms of POTS and other forms of dysautonomia.  If you have experienced it, it is frightening and extremely debilitating when it is happening on a regular basis.  
DINET has produced an excellent video about the difference between syncope and presyncope. https://youtu.be/M6MOn0vkVnA
The American College of Cardiology produced an excellent graphic to show how common syncope is in the general population 
Infographic+Syncope.pdf
edriscoll
Featured below are ongoing studies related to dysautonomia and POTS related illnesses.  DINET does its best to select the studies that we believe will best appeal to our community. If you know of a study that you would like to share with DINET, please email the information with the link to the study, to webmaster@dinet.org All information will be reviewed.  
Recruitment Studies 
NEW:  Para- and Post Infectious Autonomic Dysfunction:  The aim of this study is to identify specific infectious diseases associated with autonomic dysfunction and to identify patterns.  
Mayo Clinic, Scottsdale AZ
Contact for more information:  Marie Grill, MD, 480-301-8000 or email Grill.Marie@mayo.edu
(RESULTS) Patient research:  NIH supported research is being conducted by the Rare Disease Clinical Research Network on the impact that the COVID pandemic is having on people living with rare diseases.  You do NOT have to have been tested for COVID or have had symptoms of illness, the only criteria is to be under 90 years old and to have a rare disease.  Caretakers or parents of children with rare diseases are also encouraged to participate.  Read more about the goals of the study and the process at this link:  A summary of the survey results can be found here:   https://www.rarediseasesnetwork.org/news/2021-02-10-COVID19-survey-preliminary-results
*************************************************
COMPLETE WITH RESULTS:  Clinical Trial:  Dr. Satish Raj and the University of Calgary is recruiting POTS patients for a study of the effects of compression on the symptoms of POTS  
https://www.jacc.org/doi/10.1016/j.jacc.2020.11.040
***RECRUITING:  DINET has partnered with PCORI  (Patient-Centered Outcomes Research Institute), the University of Pittsburgh and the University of Pittsburgh Medical Center in the Story Booth project.  Research is crucial to helping us further our understanding of POTS and other forms of dysautonomia and to identify ways to prevent or cure these conditions.  That's why DINET is parterning with the Patient-Centered Outcomes Research Institute (PCORI) and the University of Pittsburgh on their MyPaTH Story Booth Project.  The project aims to help researchers better understand the dysautonomia patient experience with illness, coping and the healthcare system.  Researchers hope their findings will lead to the development of reserach studies that address topics that are important to patients and caregivers.  Please visit our Story Booth page for more detailed information or to get started sharing your story.  https://www.dinet.org/member-stories/story-booth-project-sharing-the-stories-of-patients-and-caregivers-r209/
CLOSED: (results pending) John Hopkins University is examining the use of a temporary celiac ganglion block before celiac ganglion resection in dysautonomia-related bowel dysmotility.  Autonomic celiac ganglia resection has been shown to alleviate symptoms of dysautonomia-related dysmotility by interrupting the sympathetic stimulation to the GI system.  Currently there has been no test to confirm this diagnosis pre-surgery.  This studies objection is to temporarily block the ganglion to see if the symptoms go away, therefore confirming diagnosis and allowing for the more permanent surgical action.  This study is recruiting patients with chronic dysmotility who are considering Celiac Ganglion resection.  For further criteria and information about this study, please visit:
https://clinicaltrials.gov/ct2/show/NCT04121338?term=Dysautonomia&draw=2&rank=3
Contacts:  Christos Georgiades, MD PHD cgeorgi@jhmi.edu
Beatriz Kohler, bkohler@jhmi.edu
RECRUITING:  Vanderbilt University is conducting a study entitled "Pathophysiology and therapy of Orthostatic Intolerance."  Studies to identify the role of the brain, the autonomic nervous system and the vasculature in Orthostatic Intolerance.  Blood pressure and HR are measured laying down and standing at regular intervals.  Blood samples are drawn for hormones affecting blood pressure control.  Some studies require tilt table testing and medication administration.  
Eligibility:  All participants are adults.
Contact Information:
Principles:  David Robertson, M.D., Bonnie Black, RN
Vanderbilt University, Clinical Research Center
Nashville, TN 
FAX:  615-343-8649
email:  ADCResearch@vanderbilt.edu
OPEN ENROLLMENT:  The Mayo Clinic is conducting a study to better understand the causes of autonomic disorders.  The study includes the collection of DNA for future studies.  This study is being conducted in part by Dr. Philip Low, one of the leading researchers in this field.
Eligibility:  Males and females (non-pregnant) age 13 years and older diagnosed with MSA, PAF, Autonomic Neuropathies, NOH, POTS, Dysautonomia and healthy participants.   Orthostatic range must include a systolic BP deduction of > 30 mm Hg or mean BP reduction of > 20 mm Hg that occurs within 3 mins of head-up tilt. 
For help understanding the criteria or for more information about the study, please contact Tonette Gehrking CAP at gehrking.tonette@mayo.edu or call 507-284-4462  
Participating Clinics:  Rochester, Minnesota. 
RECRUITING:  Parent-Child Dyadic Experiences Living with Postural Orthostatic Tachycardia Syndrome (POTS) during Emerging Adulthood.  What is it like living with POTS during emerging adulthood?  Virginia Tech wants to know.  If you are interested in joining a family science study on POTS, please contact Masumeh@vt.edu.  Participants must be 18-29 years old, diagnosed with POTS.  This is a parent-child study, so both must be willing to participate.  Participants must reside in the U.S.   
Virginia Polytechnic Institute and State University
Department of Human Development
Principal Investigator: Dr. Carolyn Shivers
Co-Investigator: Masumeh Farchtchi
Contact: Masumeh@vt.edu   
Specifics about the study and a consent form will be emailed to you if you are interested. 
Recruiting:  Vitamin D Deficiency in Dysautonomia  In previous work the investigator identified a group of children between the ages of 10-18 years whose diagnostic workup for chronic nausea unexplained by conventional diagnostic tests has unexpectedly revealed underlying cardiovascular instability manifesting as orthostatic intolerance, primarily defined as postural orthostatic tachycardia syndrome (POTS) (88%). While this is an atypical initial presentation for orthostatic intolerance in general, the investigator believes that the cardiovascular problem is serious and represents a cause of nausea in a majority of these individuals, as treatment of the POTS with fludrocortisone reduced the symptoms of nausea. While fludrocortisone treatment abrogates the fall in baroreflex sensitivity (BRS) during tilt in part, it did not completely correct the tachycardia symptoms or the BRS suppression during HUT. Furthermore, it caused an elevation in MAP in a supine position, which may lead to future cardiovascular problems such as early onset hypertension and cardiac hypertrophy. This argues for a different treatment approach. The investigator presents preliminary data in this application revealing that OI subjects tend to have lower 25-hydroxyvitamin D (25(OH)D) compared to non OI subjects.
Open to children 10 - 18
https://clinicaltrials.gov/ct2/show/NCT03032328?recrs=a&cond=Dysautonomia&cntry=US&draw=1&rank=13
 
Recruiting:  A Study of Pyridostigmine in Postural Tachycardia Syndrome.
This is a 3-day study being conducted by the Mayo Clinic comparing pyridostigmine vs placebo in the treatment of POTS.  Researchers expect pyridostigmine to improve tachycardia and stabilize blood pressure.
Eligibility:  Diagnosis of Postural Tachycardia Syndrome using the following criteria:
Orthostatic heart rate increment greater than or equal to 30 beats per minute (BPM) within 5 minutes of head-up tilt.
Symptoms of orthostatic intolerance. These include weakness, lightheadedness blurred vision, nausea, palpitations, and difficulty with concentration and thinking.
Both criteria must be fulfilled
See study online for exclusions and further information
http://www.mayo.edu/research/clinical-trials/cls-20128843
Mayo Clinic location, Rochester MINN, Principal Investigator:  Dr. Philip Low
Contact:  Tonette Gehrking, CAP, 507-284-4462, gehrking.tonette@mayo.edu
Recruiting:  ME/CFS Activity Patterns and Autonomic Dysfunction  The purpose of this study is to identify daily activity patterns, negative life events and autonomic abnormalities that may be related to non-improvement in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). For both naturalistic studies and behavioral intervention trials, roughly 50% of patients report worsening or unchanged illness. The proposed four-year study would be the first to look at the relationship between illness non-improvement, patient activities at home and autonomic function. Our long-range goal is to identify physiological signals and activity patterns that predict non-improvement and relapse and develop a self-management program that prescribes improvement-linked behaviors and discourages non-improvement activities.
Contact: Particia Bruckenthal, PhD, RN   631-444-1172  particia.bruckenthal@stonybrook.edu
Contact: Jenna Adamowicz, MA  631-371-4417  jenna.adamowicz@stonybrook.edu
https://clinicaltrials.gov/ct2/show/NCT02948556?recrs=a&cond=Dysautonomia&cntry=US&draw=1
STILL RECRUITING:  Study 2:  Norepinephrine Transporter Blockade, “Autonomic Failure”
This study is supported by The Food and Drug Administration’s Office of Orphan Product development. , We are testing whether we can repurpose an available drug (atomoxetine) as a treatment for neurogenic orthostatic hypotension (nOH). This study is also open to patients with MSA, pure autonomic failure (PAF), and Parkinson disease (PD) with OH.
Eligibility:  40 to 80 years old, any gender, with Neurogenic Orthostatic Hypotension (defined by a reduction of > 30 mmHg drop in SBP within 3 minutes of standing, associated with impaired autonomic reflexes as assessed by autonomic function tests.
Estimated completion date:  July 2020 
Contact:  Bonnie Black, RN, 615-*343-6862, bonnie.black@vanderbilt.edu
Contact: Jose Martinez, 212-263-7225, Jose.Martinez@nyumc.org
See study for further info and exclusions:  https://clinicaltrials.gov/ct2/show/NCT02784535
NYU Information sheet: https://dysautonomiacenter.com/2017/04/10/two-new-studies-open-for-patients-with-msa/
Recruiting:  Vagal Stimulation in POTS - The Autonomic Inflammatory Reflex (Pilot 3) 
The purpose of this study is to investigate how the electrical stimulation of a nerve in the skin of your earlobe (transcutaneous vagal nerve stimulation) affects the way your autonomic nervous system controls your heart rhythm.
Eligibility:  Participants must be female between the ages of 18-45 diagnosed with POTS.
See Study for further information and exclusions: https://www.rarediseasesnetwork.org/cms/autonomic/6111 
This study is a part of the Rare Disease Clinical Research Network and the Autonomic Disorders Consortium 
Contact:  Vanderbilt University Medical Center Nashville 
Misty Hale CCRP, 615-322-2931, misty.hale@Vanderbilt.edu
 
Still Recruiting: Two new studies open for patients with MSA 
The NYU Dysautonomia Center has 2 new clinical trials to test new drugs that are being developed for the treatment of OH in patients with MSA.  Both compounds work by enhancing the body’s levels of norepinephrine. Both studies are also being carried out at the Autonomic Dysfunction Center at Vanderbilt University.  NYU Dysautonomia Center and Vanderbilt are longtime collaborative partners in rare autonomic disorders.
NYU Information sheet:  https://dysautonomiacenter.com/2017/04/10/two-new-studies-open-for-patients-with-msa/
Recruiting:  The Big POTS Survey is still recruiting  
This study’s lead investigator is Dr. Satish Raj MD MSCI, Adjunct Professor of Medicine at Vanderbilt University’s Autonomic Dysfunction Center.  Dr. Rah says that the information collected as part of this survey “will help us learn more about the possible underlying causes and risk factors for developing POTS, treatments, and the economic, educational and social impact of POTS on patients and their families.”  Dr. Raj serves on the Medical Advisory Board for DINET and Dysautonomia International. DI is sponsoring this survey. 
https://redcap.vanderbilt.edu/surveys/?s=9rB9NkqMrC%20%20
COMPLETED:  The investigators propose to conduct a safety, tolerability and early proof of concept efficacy study of phosphatidylserine in patients with FD.  The long-term goal is to find an effection nutritional therapy that will improve the quality of life for patients with FD and alter disease prognosis  Contact & participation information is available  - https://clinicaltrials.gov/ct2/show/NCT02276716?cond=Dysautonomia&rank=5
ACTIVE NOT RECRUITING:  Clinical Trial:  University of Oklahoma and Vanderbilt University are recruiting POTS patients for the Autoimmune Basis for Postural Tachycardia Syndrome study.  They are looking at the levels of immune proteins (autoantibodies) in POTS patients and their relation to symptoms over time.  https://clinicaltrials.gov/ct2/show/NCT02725060?term=autonomic+dysfunction&cond=Postural+Orthostatic+Tachycardia+Syndrome&rank=5   
CLOSED: Clarkson University is conducting a study to learn about what factors affect the function and quality of life for people living with various chronic illnesses.  The study should take approximately 45 minutes to complete and asks similar questions to those asked by healthcare providers. Questions will include quality of sleep, fatigue, pain, etc. All answers will be anonymous. Participants must be 18 years or older. Each person participating is requested to ask one healthy person to also participate but this is not required. To learn more about this study or to begin the questionnaire, visit https://www.surveymonkey.com/r/V3P7S9J  This is an IRB exempt study. 
COMPLETED:  University of CA is studying the effect of the drug Ivabradine, a drug currently used for heart failure, to examine the possibility of its use as a treatment for heart rate issues in POTS patients.  
University of CA, San Diego
Investigator:  Pam Taub, MD
For more information: https://clinicaltrials.gov/ct2/show/NCT03182725?cond=Postural+Orthostatic+Tachycardia+Syndrome&rank=3
Completed, Results TBA  PET Imaging Study of Neurochemical and Autonomic disorders in Multiple System Atrophy (MSA) from the University of Michigan.
This study aims to better understand the patterns and timings of nerve degeneration relatively early on and how it affects symptoms and progression. 
Eligibility:  30 - 80 years old
Gender:  AllSubject:  diagnosis of MSA or probable MSA of the Parkisonion subtype (MSA-P) or Cerebellar subtype (MSA-C), Subject must be willing and able to give informed consent. Normal cognition as assessed by MiniMental State Examination
Timeline:  Less than 4 years from the time of documented diagnosis
See study online for exclusions and further information. 
https://clinicaltrials.gov/ct2/show/study/NCT02035761?recrs=ab&cond=Dysautonomia+Orthostatic+Hypotension+Syndrome&rank=4 
Contacts:  Arijit K Bhaumik, B.A. CCRP, 734-936-8281 arijit@umich.edu
Edna Rose, Ph.D., RN, MSW, BC, 734-936-7359, ednarose@umich.edu
Estimated Primary Completion Date:  July 2018
(Completed,  Results TBA) The Safety and Tolerability of Kinetin, in Patients with Familial Dysautonomia 
The overall objective of this study is to assess the safety and tolerability of administering kinetin in patients with FD. The specific aim of this proposal is to determine the safety of a once-daily dose of kinetin in patients with FD using a dose ascending titration and to determine the long-term safety and tolerability during 3-years of receiving a maximum tolerated steady state dose of kinetin. The investigators hope to also demonstrate early proof of concept that kinetin enhances the ability of the neuronal tissue to correctly splice IKAP mRNA.
Eligibility: Male or female 16 years of age and older, confirmed a diagnosis of familial dysautonomia by genetic testing, written informed consent to participate in the trial and understanding that they can withdraw consent at any time without affecting their future care. And the ability to comply with the requirements of the study procedures.
See study for more info and exclusions:  
https://clinicaltrials.gov/ct2/show/NCT02274051?cond=Dysautonomia&rank=3 
New York University School of Medicine 
Estimated Completion date:  September 2019
Contact:  Horacio Kaufmann MD, 212-263-7225,horacio.kaufmann@nyumc.org Contact:  Jose Martinez, MA, 212-263-7225, jose.martinez@nyumc.org
(CLOSED RECRUITMENT) Study 1: A Phase 2 Study to Assess the Effect and Safety of TD-9855 in Subjects with Neurogenic Orthostatic Hypotension
This Study is in collaboration with Theravance Biopharma R & D  They are testing the acute efficacy and safety of a new compound (TD-9855) in improving blood pressure and reducing orthostatic symptoms in patients that have neurogenic orthostatic hypotension (nOH), which includes those with MSA.  This study is also open to patients with Pure Autonomic Failure (PAF) and Parkinson’s Disease (PD) with NOH.
Eligibility: 40 years and older, All Genders
Diagnosed with symptomatic orthostatic hypotension due to Parkinson’s disease, MSA or PAF (ie.neurogenic orthostatic hypotension)
At screening, a subject must meet the diagnostic criteria of neurogenic orthostatic hypotension, as demonstrated by a > 30 mm Hg drop in systolic blood pressure (SBP) within 5 minutes of standing.
Impaired autonomic reflexes, as determined by the absence of BP overshoot during phase IV of the Valsalva maneuver, in subjects where Valsalva is performs as appropriate.
For the optional open-label extension study subjects must have demonstrated a pressor effect and completed dosing in Cohort 1.
Estimated completion date:  June 2018 (Completed, results not yet published)
See study for further info and exclusions: https://clinicaltrials.gov/ct2/show/NCT02705755 
 
 
edriscoll
NOTE from DINET:  The following articles and information were shared with us during the early months of the pandemic.  Although the information is still very useful and the links provided a great resource, be aware that some of the information and guidelines may have changed since the articles were written.  Please visit the CDC website for the most recent recommendations concerning masks, vaccines and safety guidelines.
COVID-19 Research: study conducted by Dr. Blitshteyn for Neurologists treating a variety of dysautonomia disorders.  Also, patient research conducted the Rare Disease Network for people living  with rare diseases, whether you have had any exposure to COVID or not.  Visit our Recruitment Studies page for info on both studies.
Statement from Dr. Peter Rowe, Director of Children's Center CFS Clinic, John Hopkins Univ. School of Medicine on COVID-19 and CFS and OI
Dysautonomia and Coronavirus - an article by Dr. Blitshteyn, one of DINET's medical advisers. 
COVID-19 Part 2 - Article by Dr. Blitshteyn, Director and Founder of the Dysautonomia Clinic.  This article tells you what to do now.
From DINET:  We live with chronic illness - tips for COVID-19 isolation  then join the forum to weigh in with your tips - POTS is like cabin fever
Important information you need to know about face masks
From the Global Genes and the Rare Disease Network
Government Updates
World Health Organization: Rolling Updates on COVID-19 World Health Organization: COVID-19 Online Courses Centers for Disease Control & Prevention: Guidelines for people at High Risk Centers for Medicare and Medicaid Services: Current Emergencies Centers for Medicare and Medicaid Services: Coronavirus (COVID-19) Partner Toolkit Cambridge Rare Disease: Current UK NHS & Government Information & Guidance City of Little Rock: Experiencing symptoms related to COVID-19? City of Little Rock: ¿Tiene síntomas relacionados con COVID-19? (Spanish) Food & Drug Administration:COVID-19 What’s New and Fast Facts National Institutes of Health: COVID-19 Updates World Health Organization: Coronavirus Information Centers for Disease Control & Prevention: Coronavirus Information Center U.S. Government: State Health Department Directory Coronavirus (COVID-19) Education & Information
Día de la Mujer Latina: Dispelling the Myths and Rumors of the New Coronavirus Disease (Webinar) Día de la Mujer Latina: Disipando los Mitos y Rumores del Nuevo Coronavirus (Webinario) GRIN2B Foundation: Flip Book Social Story SCN2A Australia: Podcast on COVID and Epilepsy Coronavirus Support Network: FAQ (English) Coronavirus Support Network: FAQ (Spanish) Coronavirus Support Network: FAQ (Portuguese) National Health Council: COVID-9 Preparedness for people with chronic disease (Webinar) Association of Community Cancer Centers: COVID-19 Resource Center American Society of Clinical Oncology: Coronavirus Resources American Academy of Neurology: COVID-19 Neurology Resource American Thoracic Society: Public Health Information Sheet American Thoracic Society: COVID-19 FAQ Financial Assistance 
Laughing at My Nightmare: COVID-19 Resource Relief Arkansas Community Foundation: Arkansas COVID Relief Fund Virtual Networking
Ehlers-Danios Society: Virtual Chat Rooms Twitter QA: #spooniechat Our Odyssey: Online Meetups The Mighty: Come Hang with the Mighty Events Support Services
Robert Wood Johnson Foundation Culture of Health Leaders: Coronavirus Support Network Global Healthy Living Foundation: COVID-19 Support Program for Chronic Disease Patients and Their Families Cancer Support Community: What Cancer Patients, Survivors, and Caregivers Need to Know About the Coronavirus Mental Health
Centers for Disease Control & Prevention: Managing Stress and Anxiety During COVID-19 Happy: Online Mental Health Support Talking to Kids
Kids Health, Nemours: How to Talk to Your Kids About COVID-9 KinderCare: Talking to Children About Coronavirus At Home Teaching Resources
District Administration: Free K-12 Resources We Are Teachers: 130+ Amazing Online Learning Resources Diagnosis, Treatments & Vaccines
Milken Institute, FasterCures: COVID-19 Treatment and Vaccine U.S. Food & Drug Administration: Clinical Trial Guidance Mindray: COVID-19 Clinical Diagnostics Webinar Episode 1 Mindray: COVID-19 Clinical Diagnostics Webinar Episode 2 Mindray: COVID-19 Clinical Diagnostics Webinar Episode 3 Mindray: COVID-19 Experts Dialogues Coverage & Benefits
Centers for Medicare & Medicaid Services: Coverage & Benefits Related to COVID-19 Medicaid and CHP Foundation Resources
Centers for Disease Control & Prevention: Communication Resources Patient Advocate Foundation: COVID-19 Operational Response Plan Nielsen Training & Consulting, LLC: COVID-19 Resources for Nonprofit Leaders Exercise
Orangetheory:  Orangetheory At Home Gold’s Gym: Stronger Anywhere Peloton: Free App Planet Fitness: Home Work-Ins Crunch: Crunch Live 305 Fitness: Group Classes Corepower Yoga: Keep Up Your Practice American Heart Association: Choose Your Own Workout Entertainment
Two Disabled Dudes: Podcast Global Genes: RARECast (Podcast) Rare in Common: Podcast Instagram Live: John Legend Instagram Live: Luke Combs Instagram Live: Coldplay, Chris Martin Instagram Live: Gentle Hours with John Mayer Global Genes: RARE Daily
×
×
  • Create New...