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Exercise Training to Improve Cardiopulmonary Hemodynamics in Heart Failure Patients

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ClinicalTrials.gov Identifier: NCT04909008
Recruitment Status : Recruiting
First Posted : June 1, 2021
Last Update Posted : November 14, 2022
Sponsor:
Collaborator:
Florida Heart Research Institute
Information provided by (Responsible Party):
Bryan Taylor, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure Pulmonary Hypertension Other: Exercise Training Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Exercise Training to Improve Pulmonary Haemodynamic and Right Ventricular Function in Heart Failure Patients With Pulmonary Hypertension
Estimated Study Start Date : March 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Cardiac Rehab
No Intervention: Control Groups
Two sets of exercise testing while continuing with standard medical care in between.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04909008


Contacts
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Contact: Erika Douglass, MPH (904) 953-6595 douglass.erika@mayo.edu
Contact: Robyn Bryde, MD (904) 953 -7274

Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Florida Heart Research Institute
Investigators
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Principal Investigator: Bryan J Taylor, PhD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Bryan Taylor, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04909008    
Other Study ID Numbers: 20-011347
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bryan Taylor, Mayo Clinic:
Exercise training
Right ventricle
Exercise capacity
Quality of life
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Heart Failure
Vascular Diseases
 Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases