CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Propranolol then Placebo +1 moredrug
Likely dose
Propranolol then Placebo 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00770484
NCT00770484N/ACompleted

Effects of Exercise in Orthostatic Intolerance

Vanderbilt University·interventional·Posted Oct 10, 2008·Updated Aug 5, 2016

In Brief

A clinical study evaluating Propranolol then Placebo and Placebo then Propranolol for Orthostatic Intolerance and Postural Tachycardia Syndrome. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2008
Enrollment StartNov 1, 2008
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 17.7 years ago

Interventions

Propranolol then Placebodrug

Propanolol 20 mg, given orally within 1 hour prior to exercising

Placebo then Propranololdrug

Placebo, matching pill given orally within 1 hour prior to exercising