Exercise Training to Improve Cardiopulmonary Hemodynamics in Heart Failure Patients

Mayo Clinic

Status: Suspended

Conditions: Heart Failure; Pulmonary Hypertension

Treatments: Other: Exercise Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04909008

20-011347

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Exercise Training

Experimental group

Description:

Two sets of exercise testing (before and after) 10 weeks of supervised exercise training (3 sessions per week) at Mayo Clinic Florida.

Treatment:

Other: Exercise Training

Control Groups

No Intervention group

Description:

Two sets of exercise testing while continuing with standard medical care in between.