An interventional study of Propranolol then Placebo and Placebo then Propranolol in Orthostatic Intolerance and Postural Tachycardia Syndrome, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-08-05.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Treatment
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:
131 studies on the registry are indexed under Postural Orthostatic Tachycardia Syndrome; 44 are open to participants now.
This study's enrollment of 12 is below the median of 36 across 98 interventional studies indexed under Postural Orthostatic Tachycardia Syndrome.
Browse Postural Orthostatic Tachycardia Syndrome studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active treatment
Drug: Propranolol then Placebo
Placebo Treatment
Drug: Placebo then Propranolol
Propanolol 20 mg, given orally within 1 hour prior to exercising
Also known as: Active
Placebo, matching pill given orally within 1 hour prior to exercising
Also known as: Inactive
Maximal Oxygen Consumption Capacity (VO2 Max)
Time frame: Over approximately 30 minutes, within 2 hours of receiving each intervention.
| Milestone | Propranolol Then Placebo | Placebo Then Propranolol |
|---|---|---|
| Started | 8 | 4 |
| Completed | 7 | 4 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| mL/kg/min | Propranolol | Placebo |
|---|---|---|
| Maximal Oxygen Consumption Capacity (VO2 Max) | 27.6 ± 1 | 24.5 ± 0.7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Propranolol Then Placebo | — | 0/8 (0%) | 0/8 (0%) |
| Placebo Then Propranolol | — | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Propranolol Then Placebo | Placebo Then Propranolol | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 4 | 12 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Years) | Propranolol Then Placebo | Placebo Then Propranolol | Total |
|---|---|---|---|
| Mean | 31 ± 3 | 32 ± 2 | 32 ± 3 |
| Sex: Female, Male(Participants) | Propranolol Then Placebo | Placebo Then Propranolol | Total |
|---|---|---|---|
| Female | 8 | 4 | 12 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Propranolol Then Placebo | Placebo Then Propranolol | Total |
|---|---|---|---|
| United States | 8 | 4 | 12 |
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Postural Orthostatic Tachycardia Syndrome→
Vanderbilt University