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

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University of Virginia

Status

Enrolling

Conditions

Heart Failure With Preserved Ejection Fraction

Treatments

Behavioral: High Intensity Interval Exercise
Behavioral: Dietary Approaches to Stop Hypertension (DASH) Diet
Behavioral: Exercise + DASH Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT05236413
HSR210393

Details and patient eligibility

About

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.

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.

Enrollment

36 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 3 patient groups

High Intensity Interval Exercise
Experimental group
Description:
Enrolled patients will perform supervised exercise on 3 nonconsecutive days of the week for 4 weeks.
Treatment:
Behavioral: High Intensity Interval Exercise
Dietary Approaches to Stop Hypertension (DASH) Diet
Experimental group
Description:
Enrolled patients will have all of their food prepared for them by a registered dietician for the duration of the study period. The diet will consist of a high fiber content DASH diet.
Treatment:
Behavioral: Dietary Approaches to Stop Hypertension (DASH) Diet
Exercise + DASH Diet
Experimental group
Description:
Enrolled subjects will undergo both the exercise training visits and be provided with the DASH diet.
Treatment:
Behavioral: Exercise + DASH Diet

Trial contacts and locations

1

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Central trial contact

Nathan Weeldreyer, MS; Siddhartha S Angadi, PhD

Data sourced from clinicaltrials.gov

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