Exercise Training to Improve Cardiopulmonary Hemodynamics in Heart Failure Patients

Heart Failure Clinical Trial

Official title:

Exercise Training to Improve Pulmonary Haemodynamic and Right Ventricular Function in Heart Failure Patients With Pulmonary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04909008
• Other study ID #: 20-011347
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: August 2026

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Erika Douglass, MPH
• Phone: (904) 953-6595
• Email: douglass.erika[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Florida Heart Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal oxygen uptake (VO2max) measured in mL/kg/min	VO2max is the maximal measured oxygen uptake during a symptom limited exercise test.	10 weeks
Secondary	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.	10 weeks
Secondary	Pulmonary vascular resistance (PVR) measured in dynes	PVR will be measured at rest and during exercise and is a measure of pulmonary hemodynamic function.	10 weeks
Secondary	Right ventricular contractile function measured as % fractional area change (RV FAC).	RV FAC is a measure of overall contractile function of the right ventricle.	10 weeks
Secondary	Left ventricular contractile function measured as % fractional area change (LV FAC).	LV FAC is a measure of overall contractile function of the left ventricle.	10 weeks
Secondary	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.	10 weeks