Mechanisms of Exercise Intolerance in Heart Failure With Preserved Ejection Fraction

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    100
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 27 May 2022
ejection fraction
dyspnea
diastolic dysfunction
heart failure with preserved ejection fraction

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.

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.

Details
Condition Heart Failure, Diastolic
Treatment exercise training
Clinical Study IdentifierNCT04068844
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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