Exercise Training to Improve Cardiopulmonary Hemodynamics in Heart Failure Patients

Not Applicable

Recruiting

• Conditions: Heart Failure; Pulmonary Hypertension
• Interventions: Other: Exercise Training

• Registration Number: NCT04909008
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-06-01
• Study Start: 2024-01-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States