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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propranolol then placebo | Experimental | Active treatment |
|
| Placebo then propranolol | Placebo Comparator | Placebo Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol then Placebo | Drug | Propanolol 20 mg, given orally within 1 hour prior to exercising |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Oxygen Consumption Capacity (VO2 Max) | Over approximately 30 minutes, within 2 hours of receiving each intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Italo Biaggioni, MD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23283362 | Derived | Gamboa A, Okamoto LE, Raj SR, Diedrich A, Shibao CA, Robertson D, Biaggioni I. Nitric oxide and regulation of heart rate in patients with postural tachycardia syndrome and healthy subjects. Hypertension. 2013 Feb;61(2):376-81. doi: 10.1161/HYPERTENSIONAHA.111.00203. Epub 2013 Jan 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Propranolol Then Placebo | Active treatment Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising |
| FG001 | Placebo Then Propranolol | Placebo Treatment Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propranolol Then Placebo | Active treatment Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising |
| BG001 | Placebo Then Propranolol | Placebo Treatment Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximal Oxygen Consumption Capacity (VO2 Max) | Posted | Mean | Standard Error | mL/kg/min | Over approximately 30 minutes, within 2 hours of receiving each intervention. |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propranolol Then Placebo | Active treatment Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Italo Biaggioni, MD., Professor of Medicine and Pharmacology | Vanderbilt University | (615) 936-3420 | italo.biaggioni@vanderbilt.edu |
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| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054972 | Postural Orthostatic Tachycardia Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Placebo then Propranolol | Drug | Placebo, matching pill given orally within 1 hour prior to exercising |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Placebo Then Propranolol | Placebo Treatment Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising | 0 | 4 | 0 | 4 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |