Exercise Training to Improve Cardiopulmonary Hemodynamics in Heart Failure Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Exercise Training to Improve Pulmonary Haemodynamic and Right Ventricular Function in Heart Failure Patients With Pulmonary Hypertension

Conditions
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Heart Failure, Pulmonary Hypertension

Intervention / Treatment
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* Other: Exercise Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NYHA functional class I-IIIb. LVEF < 40%. Clinically-stable for > 3 months [no change in disease status or medication]. Willing and able to provide written informed consent and perform cycle-ergometer or treadmill based exercise. Exclusion Criteria: NYHA class IV HF. Diagnosis of diastolic HF. Comorbidities such as obesity (BMI >36), uncontrolled systemic hypertension, type 2 diabetes, and COPD (FEV1 <50%). Musculoskeletal or other conditions that would limit exercise participation. Pregnant or nursing women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Training<br>Two sets of exercise testing (before and after) 10 weeks of supervised exercise training (3 sessions per week) at Mayo Clinic Florida. | Other: Exercise Training<br>* 10 weeks of supervised exercise training, 3 sessions per week at the cardiac rehab clinic at Mayo Clinic Florida.<br>* Other names: Cardiac Rehab;|
| No Intervention: Control Groups<br>Two sets of exercise testing while continuing with standard medical care in between. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise training, Right ventricle, Exercise capacity, Quality of life