Heart Failure Clinical Trial

The Effect of a High Fiber Diet and High-Intensity Interval Exercise in Patients With HFpEF

Summary

This study is trying to find out how best to improve common measures of health and survival in those diagnosed with heart failure with preserved ejection fraction (HFpEF) through the implementation of 4 weeks of an exercise training program consisting of high intensity interval training, dietary approaches to stop hypertension (DASH diet), or a combination of the two. Currently there are not established guidelines that have been shown to improve clinical end points in those with this HFpEF.

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Full Description

In the face of a rapidly growing population of older, HFpEF patients, there remains a need to identify ideal rehabilitative therapies to enhance improvements in the physical function of these patients. Pharmacological trials in this population have been characterized by a failure to significantly improve exercise tolerance and hard clinical outcomes and this is likely due to their singular cardiovascular focus. Exercise appears to be a promising intervention to improve cardiorespiratory fitness and reduce cardiovascular risk. Further, evidence-based dietary guidelines for patients with heart failure are lacking. Although a high-protein, low-carbohydrate diet is associated with improvements in traditional CV risk markers in patients with heart failure, it may raise cardiovascular risk in this population by adversely affecting endothelial function, increasing susceptibility to myocardial ischemia, and by inducing a pro-inflammatory state due to increased bacterial and LPS translocation through the ischemic gut. Thus, the investigators will explore the effects of the high-carbohydrate, high-fiber DASH diet due to its potential to have salutary effects on vascular risk in this population. In this study, the investigators will examine the singular and combined effects of exercise and a DASH diet in patients with HFpEF on markers of cardiovascular risk.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

≥40 years of age
Diagnosed with heart failure with preserved ejection fraction
NYHA class II-III symptoms
Physician clearance to undergo exercise training
Physician clearance to consume DASH diet
Complete COVID-19 vaccination status

Exclusion Criteria:

Unstable angina
Myocardial infarction in the past 4 weeks
Uncompensated heart failure
NYHA class IV symptoms
Complex ventricular arrhythmias
Musculoskeletal contraindications to stationary bicycling exercise
Symptomatic severe aortic stenosis
Acute pulmonary embolus
Acute myocarditis
Uncontrolled hypertension
Medication non-compliance
Unable to follow DASH diet
Food allergies (Nuts, wheat)
Pregnant women

Study is for people with:

Heart Failure

Estimated Enrollment:

36

Study ID:

NCT05236413

Recruitment Status:

Recruiting

Sponsor:

University of Virginia

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There is 1 Location for this study

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University of Virginia University Hospital
Charlottesville Virginia, 22903, United States More Info
Siddhartha S Angadi, PhD
Contact
[email protected]
Nathan Weeldreyer, MS
Contact
434-243-8677
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

36

Study ID:

NCT05236413

Recruitment Status:

Recruiting

Sponsor:


University of Virginia

How clear is this clinincal trial information?

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