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National
Dysautonomia
Research
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Clinical Research DatabaseThis database is designed to help match potential research participants with facilities that are currently conducting clinical research. NDRF provides protocol summaries only. Specific information regarding the research studies, including the associated risks and or benefits of participation, should be obtained from the investigating institution or facility. Protocols may require that an initial diagnostic evaluation be completed, covered under your insurance program, prior to any admission. This evaluation may need approval by your primary care physician and/or your insurance carrier. For this reason, you should discuss these and any other cost that you may have to incur on your initial contact with the institution conducting the research. As with any other medical matter, your physician should be contacted for answers to any medical questions. NDRF maintains this clinical research database to assist the
public in identifying ongoing or planned clinical research projects investigating the
causes of, or treatments for, Dysautonomia. For additional information on clinical research conducted at the National Institutes of Health, please visit their Clinical Center page at www.cc.nih.gov Protocol Listing:
Rush
University Medical Center
Orthostatic Intolerance - Family HistoryA research protocol investigating the possibility of genetic links for orthostatic Intolerance Conditions is currently being undertaken at Vanderbilt University's Clinical Research Center. Venous blood samples are obtained for analysis and history detailed by questionnaire. Requirements for participation in the protocol are:
Address and Contact Information:David Robertson, M.D. Pathophysiology and Therapy of Orthostatic IntoleranceThese studies include:
Address and Contact Information:David Robertson, M.D. Disorders of Catecholaminergic FunctionStudies are conducted in patients with neurocardologic disorders or disorders of catecholaminergic function. Projects involve neurochemical and physiological assessment of sympathoneural function, kinetics of catecholamine release and disposition; positron emission tomographic scanning of sympathetic innervation and function in the heart and other organs; autocrine/paracrine catecholaminergic systems such as the renal dopamine system; direct sympathetic nerve recording in humans; links between neurogenetics diseases and catecholaminergic phenotypes; and conceptual frameworks for modeling homeostatic systems during stress. Address and Contact Information:David S. Goldstein, M.D., Chief Circulatory Dysfunction in the Chronic Fatigue SyndromeWe are seeking patients aged
13-19 years old patients with chronic fatigue syndrome (CFS) who may benefit
from an NIH study (RO-1) investigating the hypothesis of circulatory dysfunction
in CFS. Recent investigations indicate that most teenagers with CFS have a form
of chronic orthostatic intolerance (the inability to remain upright without
symptoms) called the postural tachycardia syndrome (POTS) which impairs blood
flow and heart rate, and sometimes causes a fall in blood pressure. Fainting is
uncommon. These patients have symptoms of chronic orthostatic intolerance
including dizziness, fatigue, nausea, headache, pallor, and neurocognitive loss
(difficulty thinking) which overlap with the case definition of CFS. Our study
will determine how often POTS occurs in CFS, and the mechanism(s) of POTS in
individual patients. Patients will be compared to healthy control subjects. We
will also test a medication used for treating POTS which may help teenagers with
CFS. Recent results from our lab
and others suggest that low blood volume or a defect in the contraction of blood
vessels (vasoconstriction) causing a redistribution in blood accounts for
symptoms and findings in POTS. Findings are even present supine but become more
evident when upright. Defects may vary from patient to patient and changes in
limb color (e.g. purple discoloration) when upright. Prospective patients should
have other illnesses ruled out first. Following a history, physical exam and
questionnaire to see if they fit Centers for
Disease Control criteria for CFS, patients will undergo studies of blood
flow while lying down and also when gradually tilted upright. We will assess arm
and leg blood vessel properties. Simple tests of circulatory autonomic nervous
system function will also be performed. We will also measure blood hormone
levels and blood volume using a dye technique. Over a 5 week period CFS patients
will receive a drug called proamatine (midodrine) which contracts blood vessels
or a placebo (like a sugar pill) with no blood vessel properties for 2 weeks and
then will have limited retesting. After a week to allow the drug to wear off,
each patient will receive the other type of pill (placebo or drug) for 2 more
weeks and be retested again. Neither patients nor investigators will know which
order patients receive the pills until the study is over. We have already tested
a similar intravenous drug called phenylephrine in a pilot group of patients
which seems to benefit many of them without causing increased symptoms. We believe that this study
will help to determine the specific cause of POTS in CFS and will point towards
improved medical therapy for teenage patients. Please contact us through our Grant Announcement web page: NIH Grant Website Visit our general website www.syncope.org for general information about POTS, CFS and orthostatic intolerance. Vascular Control in Adolescents with Chronic Fatigue Syndrome (CFS)Preliminary data from adolescents with CFS imply that they often have increased heart rate and sympathetic tone, while heart rate variability decreases consistent with vagal withdrawal and baroreceptor failure. Blood pressure becomes poorly regulated. Head-up tilt table testing, a standard for evaluating patients with syncope, has demonstrated heart rate and blood pressure changes associated with dependent acrocyanosis and edema in CFS similar to findings in the well- described postural orthostatic tachycardia syndrome. We hypothesize that venous impairment due to abnormal blood volume or vascular mechanical properties produces dependent venous pooling and autonomic dysfunction in CFS. Normalization of vascular function should normalize autonomic function. To investigate this hypothesis, we will measure peripheral venous properties and arterial blood flows in patients with CFS in order to determine the mechanism for venous pooling. Measurements of forearm and calf blood flows, arterial resistance, and venous properties will be performed noninvasively using a technique called venous occlusion plethysmography. Patients will undergo tests of autonomic function, estimated baroreceptor sensitivity, and blood pressure and heart rate responses to routine head-up tilt at 70º. Measurements will be repeated on another day with 10º tilt increments to 35º - 45º head-up tilt. Patients will undergo a third session during which phenylephrine, esmolol and saline will be infused in order to determine the mechanism of neurovascular abnormalcy. These agents are often used therapeutically to improve CFS patients and will pinpoint effective chronic therapy. Address and Contact Information:Julian M. Stewart, M.D., Ph.D. Autonomic Research at Mount Sinai School of MedicineWe are conducting several clinical trials of new therapies for patients with dysautonomia including those with chronic autonomic failure as well as those with orthostatic intolerance of other causes. We are also conducting research studies to better understand the mechanisms of dysautonomia and to aid in its clinical diagnosis. Clinical trials currently underway and open for patient enrollment include:
All studies are approved by the Institutional Review Board (IRB) of the Mount Sinai School of Medicine. All costs and expenses related to these studies, including hospital admissions, are covered by grants, so that participating patients do not have to pay. Address and Contact Information:Horacio Kaufmann, M.D. Associate Professor of Neurology Director, Autonomic Disorders Research Program Mount Sinai School of Medicine Study of Vascular Responsiveness in Subjects With Polymorphisms of the Angiotensin II type I Receptor GeneThe purpose of this
study is to determine if differences in a number of inherited proteins influence
an individual's tendency to develop symptoms associated with blood pressure
changes while standing. It is possible that symptoms of lightheadedness,
dizziness, or passing out are related to changes in blood pressure and the
body's response to these changes. Angiotensin II is a
hormone that circulates in the blood stream and makes blood vessels constrict
(become narrow), thereby having an effect on blood pressure. It does this
by attaching to a protein on the blood vessels. We have found that
different people have different forms of this protein that attaches to the blood
vessel. The study involves analysis of DNA (from blood sample) for
differences in the gene that makes this protein. When we have looked at this
gene in many people we will see whether these differences have any effect on the
body's regulation of blood pressure. Two tubes of blood
(one tablespoon) will be taken for this study in order to obtain a supply of DNA
with which to perform the analysis. The blood samples will be stored
indefinitely at the National Institutes of Health. They may be used for
further studies related to heart disease. They may be shared with other
researchers who are doing research related to heart disease but only after the
name and all identifying information is removed. This study may increase our understanding of the causes and symptoms of low blood pressure and of heart disease. Although there may be no direct benefit to the patients, it is our belief that continued research into the cause of these conditions will provide information that will help direct diagnosis and treatment. Address and Contact Information:Rita Mincemoyer RN Research Nurse A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to Assess the Clinical Benefit of Midodrine Hydrochloride (ProAmatine®) in Patients with Neurogenic Orthostatic HypotensionWe are seeking male and female patients to voluntarily take part in a clinical research study. Patients must be aged 18 or older and diagnosed with symptomatic orthostatic hypotension (low blood pressure while in the upright position) due to Parkinson’s disease, multiple system atrophy, pure autonomic failure or autonomic neuropathies (i.e. neurogenic orthostatic hypotension). Symptoms of low blood pressure include dizziness, lightheadedness, changes in vision and generalized weakness upon standing. The main effect of the drug being studied is to increase blood pressure in the upright position so symptoms will decrease. The purpose of this clinical study is to further assess the clinical benefit of midodrine hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension. During the course of the study, participants will receive either ProAmatine® or a placebo. Assessments will be made using questionnaires that measure symptom and activity levels. Blood pressure in the lying down and standing positions will be measured at each visit. You should be aware that because ProAmatine® can cause marked elevation of blood pressure while in the lying down position, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of ProAmatine® in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, that is, an increase in systolic blood pressure measured one minute after standing, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of ProAmatine®, principally improved ability to carry out activities of daily living, have not been verified. ProAmatine® is contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicisis. ProAmatine® should not be used in patients with persistent and excessive supine hypertension. Please consult with your physician to see whether you might benefit from participation in this study. The length of this study is approximately 8 weeks with a minimum of 7 required office visits. Additional office visits may be necessary. Individual patient participation could be longer or shorter depending on the number of site visits needed. Patients will receive all study-related procedures at no charge and will be financially compensated for completed site visits. The following Investigators are participating in this study:
Autonomic Contributions to Energy Metabolism in HumansClinical Research Center, Vanderbilt University, Nashville, TN The purpose of this study is to evaluate how ANS activity may affect the variations in energy expenditure and physical activity in diseased and healthy humans. In gaining a better understanding of the relationship between the ANS and energy expenditure, better treatments may be developed for those who are obese or undernourished. Inclusion: Patients (ages 18-65) who are clinically stable with well characterized Pure Autonomic Failure (resting plasma NEpi <100 pg/ml) and Orthostatic Intolerance (standing plasma NEpi >800 pg/ml), and non-obese (BMI 21-28 kg/m2). Exclusion: Patients with known cardiovascular, renal, or liver diseases, diabetes, Parkinson's disease, pheochromocytoma, Shy-Drager syndrome, or other serious illnesses and debilitating complications will be excluded. Medications affecting energy metabolism will be stopped for the 24-hr prior to and the 24-hr during the study period. Medications affecting autonomic functions will be stopped during the 24-hr study period. Procedures include: Recording of food intake, energy expenditure (24-h stay), blood draw (20ml), exercise protocol, body composition, DEXA scan, microneurography, ECG halter monitoring, urine collection, activity patterns, and dietary log. For more information on the procedures, risks, benefits, and compensation available for those who are interested in participating in this study: Address and Contact Information:Kong Chen, Ph.D. Telephone: (615) 343-8497 Local Vasoconstriction in Postural Tachycardia SyndromeWe 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:
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The National Dysautonomia Research Foundation
(NDRF) has established this site to help inform afflicted patients, physicians
and the general public on the various forms of Dysautonomia. It is our desire to
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responsible for the misinterpretation of the information provided.
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National Institute of Neurological Disorders and Stroke
(NINDS)
National
Heart Lung and Blood Institute (NHLBI)
