Other Clinical Trial - The Effect of a High Fiber Diet & High-Intensity

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Heart Failure
Heart Failure With Preserved Ejection Fraction

Clinical Trial Details

NCT number	NCT05236413
Study type	Interventional
Source	University of Virginia
Contact	Siddhartha S Angadi, PhD
Phone	434-243-7466
Email	ssa2w@virginia.edu
Status	Recruiting
Phase	N/A
Start date	April 1, 2022
Completion date	August 1, 2025

View Details

See also
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Recruiting	`NCT03550235` - Exploration of Dyspnea at Non-high Brain Natriuretic Peptide (BNP)
Completed	`NCT04633460` - Acute Effects of Exogenous Ketone Ester Administration in Heart Failure	Phase 2
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Active, not recruiting	`NCT05284617` - Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF	Phase 2
Recruiting	`NCT05562063` - Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients	Phase 4
Recruiting	`NCT06027307` - Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation	Phase 3
Withdrawn	`NCT05322616` - Single-Ascending Dose Study of JK07 in Subjects With HFpEF	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms