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NCT00770484 · ClinicalTrials.gov registry record · NA
Effect of Exercise in OI
A NA study, sponsored by Vanderbilt University.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT00770484 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 12 participants.
The verdict
NCT00770484, a NA study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
The main limitation patients with orthostatic intolerance (OI, or postural tachycardia syndrome, POTS) have to exercise is related to their increase in heart rate when standing. Main pharmacological treatment today is aimed at reducing heart rate with the use of betablockers (propanolol), this theoretically could also improve their exercise capacity; if their heart rate do not increase as much with the medication, they could exercise more. In addition, it has been suggested that in healthy volunteers subjected to head down tilt for 2 weeks (situation that produces a "simulated" transient POTS-like state) a single bout of intense exercise can improve orthostatic tolerance the day after exercising. The mechanisms involved in such response are not that clear but could be an increase in plasma volume already diminished in POTS patients. It seems likely that the same could be true for POTS patients. The purpose of the present study are to pharmacologically improve the amount of exercise POTS patients can perform by reducing their baseline heart rate (specific aim 1) and to evaluate next day heart responses to an acute bout of intense exercise. Therefore, the specific aims of this study are: 1. To test the hypothesis that lowering heart rate response with propanolol will result in an increase in exercise capacity. 2. To test the hypothesis that a single bout of exercise will result in an improvement in orthostatic tolerance the day after exercising.
Interventions
- DRUG Propranolol then Placebo
- DRUG Placebo then Propranolol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2008-11 |
| Est. Completion | 2015-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00770484
The ClinicalTrials.gov registry entry for NCT00770484 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Propranolol then Placebo is the first listed.
NCT00770484 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00770484 about?
NCT00770484 is a clinical study titled "Effect of Exercise in OI". The main limitation patients with orthostatic intolerance (OI, or postural tachycardia syndrome, POTS) have to exercise is related to their increase in heart rate when standing. Main pharmacological treatment today is aimed at reducing heart rate with the use of betablockers (propanolol), this theor...
What is the current status of trial NCT00770484?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2008-11. Estimated completion is 2015-05.
What interventions are being tested in trial NCT00770484?
The interventions under investigation include: Propranolol then Placebo (DRUG), Placebo then Propranolol (DRUG).
Who is sponsoring clinical trial NCT00770484?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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