Exercise Training to Improve Cardiopulmonary Hemodynamics in Heart Failure Patients

Mayo Clinic40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Heart Failure Pulmonary Hypertension

Interventions

Exercise TrainingOTHER

10 weeks of supervised exercise training, 3 sessions per week at the cardiac rehab clinic at Mayo Clinic Florida.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Maximal oxygen uptake (VO2max) measured in mL/kg/min

VO2max is the maximal measured oxygen uptake during a symptom limited exercise test.

Time frame: 10 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 10 weeks

Data from ClinicalTrials.gov

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