Exercise Training to Improve Cardiopulmonary Hemodynamics in Heart Failure Patients

NCT04909008 | Suspended

• 1 other identifier: 20-011347
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Pulmonary Hypertension

Keywords

Exercise training; Right ventricle; Exercise capacity; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mean pulmonary arterial pressure (mPAP) measured in mmHg

  10 weeks

• Pulmonary vascular resistance (PVR) measured in dynes

  10 weeks

• Right ventricular contractile function measured as % fractional area change (RV FAC).

  10 weeks

• Left ventricular contractile function measured as % fractional area change (LV FAC).

  10 weeks

• Slope of the relationship between mean pulmonary arterial pressure and cardiac output (mPAP-Q slope) measured in mmHg/L/min.

  10 weeks

Study Arms (2)

Exercise Training

EXPERIMENTAL

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

Other: Exercise Training

Control Groups

NO INTERVENTION

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

Interventions

Exercise Training OTHER

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

Also known as: Cardiac Rehab

Exercise Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Florida Heart Research Institute: collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Heart Failure; Hypertension, Pulmonary

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bryan J Taylor, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized control trial

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: January 1, 2024
• Primary Completion: April 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)