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High Fiber Diet + High-Intensity Exercise for Heart Failure

N/A

Recruiting

Led By Siddhartha S Angadi, PhD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

NYHA class II-III symptoms

≥40 years of age

Must not have

Uncompensated heart failure

Acute pulmonary embolus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether 4 weeks of exercise training, eating the DASH diet, or a combination of the two can improve clinical outcomes in people with HFpEF.

Who is the study for?

This trial is for people over 40 with heart failure where the heart pumps normally (HFpEF) and mild to moderate symptoms. They must be cleared by a doctor for exercise and the DASH diet, fully vaccinated against COVID-19, and not have had recent severe heart issues or conditions that prevent them from exercising or following the diet.

What is being tested?

The study tests if high-intensity interval exercise, a healthy eating plan called the DASH diet, or both combined can improve health in those with HFpEF. Participants will follow their assigned programs for four weeks to see which method works best.

What are the potential side effects?

Potential side effects may include muscle soreness or injury from intense exercise. The DASH diet is generally safe but could cause changes in bowel habits due to increased fiber intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate to severe heart symptoms.

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I am 40 years old or older.

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I am fully vaccinated against COVID-19.

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I have been diagnosed with a type of heart failure where the heart muscle pumps normally.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart failure that is not well-managed.

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I have had a recent blood clot in my lung.

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My high blood pressure is not under control.

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I have severe symptoms from a narrowed heart valve.

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I have been diagnosed with acute myocarditis.

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I have unstable chest pain.

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I have severe heart symptoms that limit my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

VO2peak

Secondary study objectives

Blood pressure

Body Composition

Carotid-Femoral Pulse Wave Velocity

+9 more

Other study objectives

Endothelin-1

Fasting Blood Glucose

Inflammation

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: High Intensity Interval ExerciseExperimental Treatment1 Intervention

Enrolled patients will perform supervised exercise on 3 nonconsecutive days of the week for 4 weeks.

Group II: Exercise + DASH DietExperimental Treatment1 Intervention

Enrolled subjects will undergo both the exercise training visits and be provided with the DASH diet.

Group III: Dietary Approaches to Stop Hypertension (DASH) DietExperimental Treatment1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

High Intensity Interval Exercise

2021

N/A

~90

0 / 11Eligibility criteria met