Heart Failure, Pulmonary Hypertension
Conditions
Keywords
Exercise training, Right ventricle, Exercise capacity, Quality of life
Brief summary
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
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.
Interventions
OTHERExercise Training
10 weeks of supervised exercise training, 3 sessions per week at the cardiac rehab clinic at Mayo Clinic Florida.
Sponsors
Mayo Clinic
Florida Heart Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal oxygen uptake (VO2max) measured in mL/kg/min | 10 weeks | VO2max is the maximal measured oxygen uptake during a symptom limited exercise test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean pulmonary arterial pressure (mPAP) measured in mmHg | 10 weeks | mPAP will be measured at rest and during exercise and is a measure of pulmonary vascular pressure. |
| Pulmonary vascular resistance (PVR) measured in dynes | 10 weeks | PVR will be measured at rest and during exercise and is a measure of pulmonary hemodynamic function. |
| Right ventricular contractile function measured as % fractional area change (RV FAC). | 10 weeks | RV FAC is a measure of overall contractile function of the right ventricle. |
| Left ventricular contractile function measured as % fractional area change (LV FAC). | 10 weeks | LV FAC is a measure of overall contractile function of the left ventricle. |
| Slope of the relationship between mean pulmonary arterial pressure and cardiac output (mPAP-Q slope) measured in mmHg/L/min. | 10 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBryan J Taylor, PhD
Mayo Clinic
Outcome results
None listed