Mechanisms of Exercise Intolerance in Heart Failure With Preserved Ejection Fraction

Heart Failure, Diastolic Clinical Trial

Official title:

Mechanisms of Exercise Intolerance in Heart Failure With Preserved Ejection Fraction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04068844
• Other study ID #: STU-2019-0617
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic

Intervention

Behavioral:
• Exercise training
Exercise training, either whole body or isolated single leg

Locations

Country	Name	City	State
United States	The Institute for Exercise and Environmental Medicine	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	The University of Texas at Arlington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aerobic fitness	Change in peak VO2 after exercise training	4 months
Secondary	Cardiopulmonary hemodynamics	Change in exercise pulmonary capillary wedge pressure	4 months
Secondary	Sympathetic activity	Change in muscle sympathetic activity	4 months
Secondary	Leg blood flow	Change in leg blood flow assessed by Doppler velocities in femoral artery	4 months
Secondary	Cardiac fibrosis	Change in T1 mapping times by cardiac MRI	4 months