Clinical trial NCT05236413: The Effect of a High Fiber Diet and High-Intensity Interval Exercise in Patients With HFpEF
Official title: The Effect of a High Fiber Diet and High-Intensity Interval Exercise in Patients With Heart Failure With Preserved Ejection Fraction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: HIIT
DASH
High Fiber
HFpEF
heart failure
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Grain Foods Foundation
First posted: 2022-02-11
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, blinded, 3-arm parallel-group design
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: VO2peak
timeFrame: 4 weeks
Secondary outcomes:
measure: Diastolic Function
timeFrame: 4 weeks
measure: Ejection Fraction
timeFrame: 4 weeks
measure: Global Longitudinal Strain
timeFrame: 4 weeks
measure: Blood pressure
timeFrame: 4 weeks
measure: Carotid-Femoral Pulse Wave Velocity
timeFrame: 4 weeks
measure: Body Composition
timeFrame: 4 weeks
measure: Physical Activity Enjoyment Scale
timeFrame: Immediately after the intervention
measure: Minnesota Living with Heart Failure Questionnaire
timeFrame: 4 weeks
measure: Epworth Sleepiness Questionnaire
timeFrame: 4 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 4 weeks
measure: Circadian Type Questionnaire
timeFrame: 4 weeks
measure: Sleep Apnea
timeFrame: 4 weeks
Other outcomes:
measure: NTproBNP
timeFrame: 4 weeks
measure: Inflammation
timeFrame: 4 weeks
measure: Lipids
timeFrame: 4 weeks
measure: Insulin
timeFrame: 4 weeks
measure: Fasting Blood Glucose
timeFrame: 4 weeks
measure: Endothelin-1
timeFrame: 4 weeks
measure: Lipopolysaccharide
timeFrame: 4 weeks
measure: Trimethylamine-N-oxide
timeFrame: 4 weeks
Locations:
city: Charlottesville
country: United States
facility: University of Virginia University Hospital
state: Virginia
Study officials:
affiliation: University of Virginia
name: Siddhartha S Angadi, PhD
role: PRINCIPAL_INVESTIGATOR
References: