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Mechanisms of Exercise Intolerance in Heart Failure With Preserved Ejection Fraction

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ClinicalTrials.gov Identifier: NCT04068844
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
University of Texas-Arlington
Information provided by (Responsible Party):
Benjamin Levine, University of Texas Southwestern Medical Center

Brief Summary:
The global objective of this study is to determine the mechanisms of exercise intolerance and dyspnea on exertion (DOE) in patients with HFpEF and based on this pathophysiology, test whether specific exercise training programs (whole body vs single leg) will result in improved exercise tolerance.

Condition or disease Intervention/treatment Phase
Heart Failure, Diastolic Behavioral: Exercise training Not Applicable

Detailed Description:
This will be a randomized, non-blinded prospective intervention testing the effects of two types of exercise training, whole body and isolated single leg, on HFpEF patients with either central or peripheral limitations to exercise training. Subjects will undergo baseline maximal exercise testing and invasive right heart catheterization to define exercise tolerance and pulmonary and cardiac pressures during exercise. Based on the results of baseline testing, subjects will be divided into either centrally limited, defined as excessive rise in pulmonary capillary wedge pressure more than 25 mmHg that decreases after administration of sub-lingual nitroglycerin resulting in improved exercise tolerance, or peripherally limited, defined as no improvement in exercise tolerance despite reduction in pulmonary capillary wedge pressure after sublingual nitroglycerin. After baseline testing, subjects will be randomized to either whole body cycle exercise supplemented with sublingual nitroglycerin to improve training responsiveness or isolated single leg exercise training for 4 months. After 4 months, subjects will repeat maximal exercise testing and invasive right heart catheterization to assess responses to 4 months of exercise training.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: HFpEF patients with either central or peripheral limitations to exercise will be randomly assigned to either whole body or isolated single leg exercise.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanisms of Exercise Intolerance in Heart Failure With Preserved Ejection Fraction
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Central HFpEF whole body exercise
HFpEF patients who have a central limitation as the cause of the exercise intolerance randomized to whole body cycle training.
Behavioral: Exercise training
Exercise training, either whole body or isolated single leg

Experimental: Central HFpEF isolated single leg exercise
HFpEF patients who have a central limitation as the cause of the exercise intolerance randomized to isolated single leg training.
Behavioral: Exercise training
Exercise training, either whole body or isolated single leg

Experimental: Peripheral HFpEF whole body exercise
HFpEF patients who have a peripheral limitation as the cause of the exercise intolerance randomized to whole body cycle training.
Behavioral: Exercise training
Exercise training, either whole body or isolated single leg

Experimental: Peripheral HFpEF isolated single leg exercise
HFpEF patients who have a peripheral limitation as the cause of the exercise intolerance randomized to isolated single leg training.
Behavioral: Exercise training
Exercise training, either whole body or isolated single leg




Primary Outcome Measures :
  1. Aerobic fitness [ Time Frame: 4 months ]
    Change in peak VO2 after exercise training


Secondary Outcome Measures :
  1. Cardiopulmonary hemodynamics [ Time Frame: 4 months ]
    Change in exercise pulmonary capillary wedge pressure

  2. Sympathetic activity [ Time Frame: 4 months ]
    Change in muscle sympathetic activity

  3. Leg blood flow [ Time Frame: 4 months ]
    Change in leg blood flow assessed by Doppler velocities in femoral artery

  4. Cardiac fibrosis [ Time Frame: 4 months ]
    Change in T1 mapping times by cardiac MRI



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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • signs and symptoms of heart failure
  • an ejection fraction > 0.50
  • objective evidence of diastolic dysfunction

Exclusion Criteria:

  • age < 60 years
  • BMI > 50 kg/m2
  • PDE5 inhibitor use
  • Severe valvular disease
  • Severe COPD
  • CKD 4 or higher
  • Contra-indication to MRI.

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): NCT04068844


Locations
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United States, Texas
The Institute for Exercise and Environmental Medicine Recruiting
Dallas, Texas, United States, 75231
Contact: Mary B Childers    214-345-6459    MaryBChilders@texashealth.org   
Principal Investigator: Benjamin D Levine, M.D.         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
University of Texas-Arlington

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Responsible Party: Benjamin Levine, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04068844     History of Changes
Other Study ID Numbers: STU 2019-0617
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Benjamin Levine, University of Texas Southwestern Medical Center:
Exercise
Hemodynamics,
Heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases