Exercise Training to Improve Cardiopulmonary Hemodynamics in Heart Failure Patients

March 27, 2024 updated by: Bryan Taylor, Mayo Clinic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Robyn Bryde, MD
  • Phone Number: (904) 953 -7274

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Training
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
10 weeks of supervised exercise training, 3 sessions per week at the cardiac rehab clinic at Mayo Clinic Florida.
Other Names:
  • Cardiac Rehab
No Intervention: Control Groups
Two sets of exercise testing while continuing with standard medical care in between.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal oxygen uptake (VO2max) measured in mL/kg/min
Time Frame: 10 weeks
VO2max is the maximal measured oxygen uptake during a symptom limited exercise test.
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean pulmonary arterial pressure (mPAP) measured in mmHg
Time Frame: 10 weeks
mPAP will be measured at rest and during exercise and is a measure of pulmonary vascular pressure.
10 weeks
Pulmonary vascular resistance (PVR) measured in dynes
Time Frame: 10 weeks
PVR will be measured at rest and during exercise and is a measure of pulmonary hemodynamic function.
10 weeks
Right ventricular contractile function measured as % fractional area change (RV FAC).
Time Frame: 10 weeks
RV FAC is a measure of overall contractile function of the right ventricle.
10 weeks
Left ventricular contractile function measured as % fractional area change (LV FAC).
Time Frame: 10 weeks
LV FAC is a measure of overall contractile function of the left ventricle.
10 weeks
Slope of the relationship between mean pulmonary arterial pressure and cardiac output (mPAP-Q slope) measured in mmHg/L/min.
Time Frame: 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.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Florida Heart Research Institute

Investigators

  • Principal Investigator: Bryan J Taylor, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

May 26, 2021

First Submitted That Met QC Criteria

May 26, 2021

First Posted (Actual)

June 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-011347

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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