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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
VO2peak
Secondary outcome measures
Blood pressure
Body Composition
Carotid-Femoral Pulse Wave Velocity
+9 moreOther outcome measures
Endothelin-1
Fasting Blood Glucose
Inflammation
+5 moreTrial 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
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,245,037 Total Patients Enrolled
11 Trials studying Heart Failure
1,516 Patients Enrolled for Heart Failure
Grain Foods FoundationUNKNOWN
Siddhartha S Angadi, PhDPrincipal InvestigatorUniversity of Virginia
3 Previous Clinical Trials
117 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate to severe heart symptoms.You have allergies to nuts or wheat.You are unable to follow the DASH diet.My doctor has approved me for exercise training.I have heart failure that is not well-managed.I have had a recent blood clot in my lung.I am 40 years old or older.I am fully vaccinated against COVID-19.You have complicated heart rhythm problems.I have been diagnosed with a type of heart failure where the heart muscle pumps normally.My doctor has approved me to follow the DASH diet.My high blood pressure is not under control.I have had a heart attack in the last 4 weeks.You have a condition that makes it unsafe for you to do stationary biking.I have severe symptoms from a narrowed heart valve.I have been diagnosed with acute myocarditis.I have unstable chest pain.I have severe heart symptoms that limit my daily activities.You do not follow the instructions for taking your medication.
Research Study Groups:
This trial has the following groups:- Group 1: Dietary Approaches to Stop Hypertension (DASH) Diet
- Group 2: High Intensity Interval Exercise
- Group 3: Exercise + DASH Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to participate in this experiment presently?
"Data hosted on clinicaltrials.gov suggests that this particular medical trial is no longer recruiting test subjects, as the most recent update was made on February 10th 2022. Despite this fact, there are still 702 other studies actively seeking participants at present time."
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