The Effect of a High Fiber Diet and High-Intensity Interval Exercise in Patients With Heart Failure With Preserved Ejection Fraction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Virginia
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- VO2peak
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcomes assessor will be blinded to group allocations. Subjects will know which group they have been randomized to.
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
VO2peak
Time Frame: 4 weeks
Change in VO2peak (L/min) measured pre- and post-intervention
Secondary Outcomes
- Body Composition(4 weeks)
- Diastolic Function(4 weeks)
- Pittsburgh Sleep Quality Index(4 weeks)
- Global Longitudinal Strain(4 weeks)
- Circadian Type Questionnaire(4 weeks)
- Blood pressure(4 weeks)
- Minnesota Living with Heart Failure Questionnaire(4 weeks)
- Epworth Sleepiness Questionnaire(4 weeks)
- Ejection Fraction(4 weeks)
- Carotid-Femoral Pulse Wave Velocity(4 weeks)
- Physical Activity Enjoyment Scale(Immediately after the intervention)
- Sleep Apnea(4 weeks)
Investigators
Siddartha Angadi
Assistant Professor
University of Virginia