- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04140721
Autonomic Determinants of POTS - Pilot 2
Autonomic Determinants of Postural Tachycardia Syndrome (Chronic Pilot Study 2)
Postural tachycardia syndrome (POTS) is a relatively common condition affecting mostly otherwise healthy young women. These patients have high heart rate and disabling symptoms during standing. Quality of life may be poor. The sympathetic nerves in the autonomic nervous system help to maintain normal blood pressures and heart rates during activities of daily life.
The purpose of this study is to determine the importance of sympathetic activation as a cause of orthostatic symptoms. The investigators will assess the effects of a blood pressure medication (Moxonidine) on the symptoms during standing. Moxonidine lowers sympathetic activity. The investigators believe patients with high resting sympathetic activity might benefit from Moxonidine. It might reduce high heart rate and improve symptoms during standing. This study should help clinicians and the growing population of patients with POTS gain a better understanding of this disorder and find more personalized treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Andre Diedrich, MD, PhD
- Phone Number: (615) 343-6499
- Email: autonomics@vumc.org
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37221
- Recruiting
- Vanderbilt University Medical Center
-
Contact:
- Andre Diedrich, MD, PhD
- Phone Number: 615-343-6499
- Email: autonomics@vumc.org
-
Contact:
- Thomas Cayton, RN
- Phone Number: (615) 875-6731
- Email: autonomics@vumc.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
meets criteria for postural tachycardia syndrome (POTS)
- a heart rate increase of ≥30 beats/min within 10 minutes of upright posture;
- lack of orthostatic hypotension (blood pressure fall ≥ 20/10 mmHg within 3 minutes of standing); and
- chronic symptoms during upright posture over at least 6 months, in the absence of any other acute cause.
- in the follicular phase of the menstrual cycle (days 5-13 of a 28-day cycle)
- POTS with primary central sympathetic activation (psPOTS) as defined as having resting MSNA ≥ 25 bursts/min
- able and willing to provide informed consent.
Exclusion Criteria:
- pregnancy,
- smoker,
- BMI>30 kg/m2,
- deconditioned status (if available VO2max<80% of predicted)
- unable to withdraw from medications known to affect autonomic function, blood pressure or blood volume
- systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies.
- arteriosclerotic disease of carotid artery. History of neck surgery.
- conditions associated with inflammatory processes, such as coronary artery disease, hypertension, smoking, hypercholesterolemia (or on statin therapy), rheumatoid arthritis, diabetes,
- treatment with oral corticosteroids, current infections (e.g., urinary tract infection), or use of non-steroidal anti-inflammatory drugs.
- other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Moxonidine then Placebo
After screening/baseline evaluations, patients will be discharged home on moxonidine 0.2-0.4
mg/day PO.
After two weeks, the patients will be re-admitted for study testing while on moxonidine.
At completion of this testing, patients will start taking matching placebo once daily PO to be continued at home.
After two, the patients will be re-admitted for study testing while on placebo.
|
Placebo pill identical to moxonidine administered for 4 weeks
Other Names:
Moxonidine pill administered for 4 weeks
Other Names:
|
Experimental: Placebo then Moxonidine
After screening/baseline evaluations, patients will be discharged home on placebo identical to moxonidine once daily PO.
After two weeks, the patients will be re-admitted for study testing while on placebo.
At completion of this testing, patients will start taking moxonidine 0.2-0.4
mg/day PO to be continued at home.
After two weeks, the patients will be re-admitted for study testing while on moxonidine.
|
Placebo pill identical to moxonidine administered for 4 weeks
Other Names:
Moxonidine pill administered for 4 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Orthostatic Symptom Burden [delta (delta VOSS)]
Time Frame: after 30 min supine to after 15 min of 60 degrees upright tilt (delta VOSS), 2-3 hours after a dose of the treatment assigned for the previous period.
|
VOSS is a validated questionnaire that consists of 9 items: mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea.
Each item is scored on a 0 to 10 scale (with 0 reflecting absence of symptoms), and the change of the total scores (range: 0-90) from supine to upright postures (delta VOSS) will be used as a measure of orthostatic symptom burden.
The primary outcome measure will be the difference in orthostatic symptom burden [delta (delta VOSS)] following 4 weeks of placebo vs. moxonidine treatment.
|
after 30 min supine to after 15 min of 60 degrees upright tilt (delta VOSS), 2-3 hours after a dose of the treatment assigned for the previous period.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Orthostatic Change in Heart Rate [delta (delta HR)]
Time Frame: after 30 min supine to after 15 min of 60 degrees upright tilt (delta HR), 2-3 hours after a dose of the treatment assigned for the previous period.
|
Difference in heart rate change from supine to upright postures (delta HR) following 4 weeks of placebo vs. moxonidine treatment [delta (delta HR)].
|
after 30 min supine to after 15 min of 60 degrees upright tilt (delta HR), 2-3 hours after a dose of the treatment assigned for the previous period.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Andre Diedrich, MD, PhD, Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Nervous System Diseases
- Disease
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Autonomic Nervous System Diseases
- Primary Dysautonomias
- Orthostatic Intolerance
- Syndrome
- Tachycardia
- Postural Orthostatic Tachycardia Syndrome
- Antihypertensive Agents
- Moxonidine
Other Study ID Numbers
- VANDERBILT_IRB_191749
- R01HL142583 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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