Mechanisms of Exercise Intolerance in Heart Failure With Preserved Ejection Fraction
- Conditions
- Heart Failure, Diastolic
- Interventions
- Behavioral: Exercise training
- Registration Number
- NCT04068844
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief Summary
The global objective of this study is to determine the mechanisms of exercise intolerance and dyspnea on exertion (DOE) in patients with HFpEF and based on this pathophysiology, test whether specific exercise training programs (whole body vs single leg) will result in improved exercise tolerance.
- Detailed Description
This will be a randomized, non-blinded prospective intervention testing the effects of two types of exercise training, whole body and isolated single leg, on HFpEF patients with either central or peripheral limitations to exercise training. Subjects will undergo baseline maximal exercise testing and invasive right heart catheterization to define exercise tolerance and pulmonary and cardiac pressures during exercise. Based on the results of baseline testing, subjects will be divided into either centrally limited, defined as excessive rise in pulmonary capillary wedge pressure more than 25 mmHg that decreases after administration of sub-lingual nitroglycerin resulting in improved exercise tolerance, or peripherally limited, defined as no improvement in exercise tolerance despite reduction in pulmonary capillary wedge pressure after sublingual nitroglycerin. After baseline testing, subjects will be randomized to either whole body cycle exercise supplemented with sublingual nitroglycerin to improve training responsiveness or isolated single leg exercise training for 4 months. After 4 months, subjects will repeat maximal exercise testing and invasive right heart catheterization to assess responses to 4 months of exercise training.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 93
- signs and symptoms of heart failure
- an ejection fraction > 0.50
- objective evidence of diastolic dysfunction
- age < 60 years
- BMI > 50 kg/m2
- PDE5 inhibitor use
- Severe valvular disease
- Severe COPD
- CKD 4 or higher
- Contra-indication to MRI.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Peripheral HFpEF whole body exercise Exercise training HFpEF patients who have a peripheral limitation as the cause of the exercise intolerance randomized to whole body cycle training. Central HFpEF whole body exercise Exercise training HFpEF patients who have a central limitation as the cause of the exercise intolerance randomized to whole body cycle training. Central HFpEF isolated single leg exercise Exercise training HFpEF patients who have a central limitation as the cause of the exercise intolerance randomized to isolated single leg training. Peripheral HFpEF isolated single leg exercise Exercise training HFpEF patients who have a peripheral limitation as the cause of the exercise intolerance randomized to isolated single leg training.
- Primary Outcome Measures
Name Time Method Aerobic fitness 4 months Change in peak VO2 after exercise training
- Secondary Outcome Measures
Name Time Method Sympathetic activity 4 months Change in muscle sympathetic activity
Cardiac fibrosis 4 months Change in T1 mapping times by cardiac MRI
Cardiopulmonary hemodynamics 4 months Change in exercise pulmonary capillary wedge pressure
Leg blood flow 4 months Change in leg blood flow assessed by Doppler velocities in femoral artery
Trial Locations
- Locations (1)
The Institute for Exercise and Environmental Medicine
🇺🇸Dallas, Texas, United States