Patient Resources
Ongoing Clinical Studies


Clinical research is needed to advance our knowledge about the cause of disease and to develop new treatments.  Although progress is being done, medical research is often a slow process and it is not certain that patients who volunteer will directly benefit from the research they participate in.  It is important that they understand the potential benefits and risks before deciding to participate.

In the following listing, a brief description of ongoing clinical studies is provided, along with contact information.

Physicians and patients should recognize that the American Autonomic Society does not endorse or recommend particular studies.

You can obtain general information about clinical research here

If you are a member of the society, and want to be included in this listing, click here


Multicenter Trials:

New

Chelsea Therapeutics is sponsoring a trial to determine the safety and efficacy of droxidopa for the treatment of orthostatic hypotension. More information: For Physicians, For Patients

Geographical Listing: 

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Research Study on Dizziness
Volunteers wanted for a research study that evaluates the effects of a breathing device on blood pressure control in subjects diagnosed with orthostatic hypotension. Study evaluates the effects of a breathing device that improves circulation on blood pressure and blood flow in the brain during standing. 

Looking for 20 participants (age 40-85 years) with:
·  Low blood pressure while standing
·
  Fainting or dizziness
·
  Orthostatic hypotension

Beth Israel Deaconess Medical Center, Boston
If interested, please call:
617-667-1777 Chelsea Kantor 


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Abnormalities in Regulation of Blood Flow in Posturla Tachycardia Syndrome
    We are seeking patients aged 15-29 years old with postural tachycardia syndrome (POTS) for an investigation of abnormalities of regulation of blood flow. Many people are unable to remain upright for long because of symptoms such as dizziness, nausea and headache. This may occur on a day-to-day basis and may severely compromise lifestyle. The most common cause of this condition is the postural tachycardia syndrome (POTS). POTS is defined by an abnormal increase in heart rate (“tachycardia”) and symptoms that occur when upright (therefore “postural”).
    POTS has many causes, all related to an abnormal decrease in the amount of blood returning to the heart. It is a problem in blood flow regulation. Blood flow regulation is partly due to the autonomic nervous system and partly due to local factors. It is these local factors that we are currently studying.
    Your own doctor can rule out other illnesses which can produce similar symptoms. In addition you may have seen a cardiologist, a neurologist, or an endocrinologist. Tests such as tilt table tests may have already been performed. Some of these tests may be repeated.
    However, we will perform other minimally invasive tests that are not ordinarily available to your doctor. They are, however, all approved ways of measuring how blood vessels work. The tests performed during the study may help us determine what treatment is best for you.
   
If you would like to take part in this study, please read further at our website, www.syncope.org where there is a link to detailed study information. Then, please get in touch with us. The study coordinator will contact you to arrange for an appointment for the study. Testing lasts two days. The study may help to determine the specific biochemical causes of POTS and will point towards improved medical therapy for young patients.

Address and Contact Information:
        Nicolette Walters, Research Coordinator
        Telephone: (914) 593-8888
        email:
 Nicolette_Walters@NYMC.edu
Julian M. Stewart, M.D., Ph.D.
Director, The Center for Hypotension
Maria Fareri Children's Hospital
New York Medical College
Valhalla, New York
Telephone: (914) 593-8888
email: stewart@nymc.edu

Vascular Dysfunction in Chronic Fatigue Syndrome

We are investigating “Vascular Dysfunction in CFS” in the young. This means problems with blood vessels. In many young CFS patients we have already demonstrated a circulatory problem called postural tachycardia syndrome or POTS. Our understanding of the mechanisms of POTS is incomplete and not all young CFS patients have POTS. We have proposed that even though some CFS patients do not have POTS, they may still have problems with small blood vessels that can be detected in skin.

When you come for your testing, we will perform a type of tilt testing to determine whether you have POTS or not. We will also determine the type of POTS. If you do not have POTS, we will complete testing in two days using a technique called intradermal microdialysis which is explained in the consent and in the website (www.syncope.org) .

If you agree and have CFS with POTS we invite you to stay with us for 4 days of testing which includes testing of potential treatments.

Characteristics of the patients (inclusion/exclusion criteria in lay terms)
Age 15-29 years with chronic fatigue syndrome. No other systemic illnesses.

Contact Information: Courtney Terilli BS, RN Nurse Research Coordinator
Courtney_Terilli@nymc.edu

Julian M. Stewart, M.D., Ph.D.
Director, The Center for Hypotension
Maria Fareri Children's Hospital
New York Medical College
Valhalla, New York
Telephone: (914) 593-8888
email: stewart@nymc.edu


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Causes and Treatment of Autonomic Failure
The goal of this study is to investigate the causes leading to primary disorders of the autonomic nervous system (e.g., Pure Autonomic Failure, Shy Drager syndrome or MSA), and to develop new treatment for the blood pressure problems that develop in these patients (low blood pressure on standing, high blood pressure while lying down).

Patients with a fall in blood pressure of at least 30 points on standing.

Contact information:
Bonnie Black , RN 
AA-3228 MCN
Vanderbilt University
Nashville, TN 37232
bonnie.black@vanderbilt.edu

See also our website:  http://www.mc.vanderbilt.edu/gcrc/adc/index.html


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Gender & Orthostatic Intolerance: Mechanisms and Therapy
           
The purposes of this clinical research are 1) to study why patients with Postural Orthostatic Tachycardia Syndrome (POTS) are primarily young women; and 2) to seek an effective therapy for the patients with POTS. This research is being done because factors contributing to orthostatic intolerance (difficulty tolerating standing upright) remain unclear. In addition, whether exercise training can be regarded as an effective therapy for patients with POTS compared with standard pharmacologic therapies (such as using FDA approved drugs to slow down pulse or to increase body fluid volume) needs to be determined.

Patient characteristics:
If you are a premenopausal woman and have had intolerable light-headedness, dizziness, weakness, and even pass out when standing upright, and these symptoms have been present for over 6 months; if after standing for 5 to 10 minutes, your heart rate increases more than 30 beats per minute or your heart rate is over 120 beats per minute; if your upright plasma norepinephrine (adrenaline-like substance) is very high (over 600 pg/ml); if there are no known causes such as dehydration, medications, a debilitating disease, etc., and you are otherwise healthy, you are potentially eligible for this research.  

Contact Information:
Diane Bedenkop, R.N.
Institute for Exercise and Environmental Medicine at Presbyterian Hospital of Dallas
The University of Texas Southwestern Medical Center at Dallas
7232 Greenville Avenue, Suite 435
Dallas
, Texas 75231
Phone: (214) 345-4654
Fax: (214) 345-4618
Email: DianeBedenkop@texashealth.org

Disease on interest (check all that apply)
 X  POTS/Orthostatic Intolerance    
__ Pure autonomic failure
__ Multiple System Atrophy/Shy Drager
__ Neurogenic/vasovagal syncope
__ Diabetes
__ Familial Dysautonomia

 


 

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Norepinephrine transporter and neurocardiogenic syncope
The study investigates the relevance of the norepinephrine transporter for the occurrence of syncope during head-up tilt.
Patients with recurrent syncope will undergo a detailed screening including a head-up tilt test to make a diagnosis of the suspected cause of syncope. Patients with confirmed neurocardiogenic syncope during head-up tilt will then be tested twice on two separate days, in a double-blind, randomized, cross-over study, once after the ingestion of reboxetine, and once after placebo. Reboxetine is a drug that selectively inhibits the reuptake of norepinephrine. Reboxetine is approved in Germany for the treatment of depression.
Testing consists of a serious of autonomic function tests, a head-up tilt test, and repeated blood samples.

Characteristics of the patients (inclusion/exclusion criteria in lay terms)

Contact Information:
Dr. Christoph Schroeder
Franz-Volhard Clinical Research Center
Medical University Charité
Campus Buch
Wiltbergstr. 50
13125 Berlin
Germany
Tel.: +49 30 9417-2581
Fax: +49 30 9417-2265
Email: schroeder@fvk.charite-buch.de


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Orthostatic intolerance, Orthostatic Hypotension in Children
 Patients with orthostatic symptoms are properly diagnosed by active standing and tilting test with portapres and NIRS, and are treated using a counter-pressure garment (an inflatable abdominal band) in  addition to diet and medication.

 Patient characteristics:
 Having orthostatic symptoms or chronic fatigue with or without school  absenteeism

Contact Information:
 www.inphs.gr.jp

 Disease on interest (check all that apply)
 _x_POTS/Orthostatic Intolerance
 _x_Pure autonomic failure
 __Multiple System Atrophy/Shy Drager
 _x_Neurogenic/vasovagal syncope
 __Diabetes
 __Familial Dysautonomia
 __Others:


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