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| Name | Class |
|---|---|
| Florida Heart Research Institute | OTHER |
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This research study is being done to find out if exercise therapy can help improve the heart function, overall health, and quality of life of patients with pulmonary hypertension caused by heart failure.
The purpose of this research is to see if taking part in structured exercise training will improve the ability to exercise, the function of the heart, and the function of the blood vessels that supply the lungs in patients with heart failure and pulmonary hypertension. After enrollment all patients will complete exercise testing. Patients will be randomized to either 10 weeks of exercise training (3 times per week) or will continue standard medical care. All patients will undergo detailed exercise testing before and after the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Training | Experimental | Two sets of exercise testing (before and after) 10 weeks of supervised exercise training (3 sessions per week) at Mayo Clinic Florida. |
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| Control Groups | No Intervention | Two sets of exercise testing while continuing with standard medical care in between. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Training | Other | 10 weeks of supervised exercise training, 3 sessions per week at the cardiac rehab clinic at Mayo Clinic Florida. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal oxygen uptake (VO2max) measured in mL/kg/min | VO2max is the maximal measured oxygen uptake during a symptom limited exercise test. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean pulmonary arterial pressure (mPAP) measured in mmHg | mPAP will be measured at rest and during exercise and is a measure of pulmonary vascular pressure. | 10 weeks |
| Pulmonary vascular resistance (PVR) measured in dynes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan J Taylor, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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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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Randomized control trial
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PVR will be measured at rest and during exercise and is a measure of pulmonary hemodynamic function.
| 10 weeks |
| Right ventricular contractile function measured as % fractional area change (RV FAC). | RV FAC is a measure of overall contractile function of the right ventricle. | 10 weeks |
| Left ventricular contractile function measured as % fractional area change (LV FAC). | LV FAC is a measure of overall contractile function of the left ventricle. | 10 weeks |
| Slope of the relationship between mean pulmonary arterial pressure and cardiac output (mPAP-Q slope) measured in mmHg/L/min. | The mPAP-Q slope during exercise is a measure of the pulmonary hemodynamic response to exercise. A slope >3 is 'abnormal', and a steeper slope is related to poorer pulmonary hemodynamic function. | 10 weeks |
| D006973 |
| Hypertension |
| D014652 | Vascular Diseases |