- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05236413
The Effect of a High Fiber Diet and High-Intensity Interval Exercise in Patients With HFpEF
The Effect of a High Fiber Diet and High-Intensity Interval Exercise in Patients With Heart Failure With Preserved Ejection Fraction
Study Overview
Status
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Siddhartha S Angadi, PhD
- Phone Number: 434-243-7466
- Email: ssa2w@virginia.edu
Study Contact Backup
- Name: Nathan Weeldreyer, MS
- Phone Number: 434-243-8677
- Email: nw8ky@virginia.edu
Study Locations
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-
Virginia
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Charlottesville, Virginia, United States, 22903
- Recruiting
- University of Virginia University Hospital
-
Contact:
- Nathan Weeldreyer, MS
- Phone Number: 434-243-8677
- Email: nw8ky@virginia.edu
-
Contact:
- Siddhartha S Angadi, PhD
- Email: ssa2w@virginia.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High Intensity Interval Exercise
Enrolled patients will perform supervised exercise on 3 nonconsecutive days of the week for 4 weeks.
|
Patients will be required to report for three sessions of supervised stationary cycling exercise per week over a period of 4-weeks. Training heart rates will be determined based on the pre-testing VO2peak and peak heart rate (PHR). All sessions will be supervised by trained personnel. Patients will start with eight intervals of 2-min duration at 80-85% of PHR, separated by 2 min of recovery at 50% of PHR, progressing to four, 4-min intervals at 90-95% PHR, separated by 3 min at 50% PHR by the end of week 2. Each training session will begin with a 10-min warm-up at 50% of PHR and end with a 5-min cool down at 50% PHR. Subjects will be weighed prior to every exercise session and weight tracked to ensure that their volume status hasn't changed significantly. Subjects will be instructed to maintain usual levels of physical activity and usual diet during the study and not to make any modifications to the same. |
Experimental: Dietary Approaches to Stop Hypertension (DASH) Diet
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.
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Patients will be interviewed with regard to their food/religious preferences and food allergies and a 7-day rotating meal plan will be designed per their preferences along with a registered dietitian.
This will ensure that patients receive food that is acceptable to them.
Participants will then be provided pre-packaged meals for 4-weeks with macronutrient compositions as follows - (Carbohydrates -55-60%, Protein -15-20%, Fat -15-25%, Fiber -35-45g/day).
All foods will be labeled, sealed, and packed for weekly delivery and will be designed such that they can be refrigerated or frozen and stored without significant alterations to nutritional content.
All food will be prepared by the UVA Hospital Nutrition Services department in conjunction with a registered dietician.
Deviations (if any) from the study meal plan will be recorded by the participants in a food record provided at the start of each diet intervention period.
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Experimental: Exercise + DASH Diet
Enrolled subjects will undergo both the exercise training visits and be provided with the DASH diet.
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Patients will undergo both the exercise training intervention and DASH diet as explained above.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2peak
Time Frame: 4 weeks
|
Change in VO2peak (L/min) measured pre- and post-intervention
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diastolic Function
Time Frame: 4 weeks
|
E' and A' (cm/s) will be used to calculate the E'/A' ratio to assess for diastolic dysfunction and be measured by echocardiogram pre- and post-intervention
|
4 weeks
|
Ejection Fraction
Time Frame: 4 weeks
|
Ejection fraction (%) will be used to assess changes in cardiac contractile function and be measured by echocardiogram pre- and post-intervention
|
4 weeks
|
Global Longitudinal Strain
Time Frame: 4 weeks
|
Global longitudinal strain (%) will be used to assess changes in cardiac contractile function and be measured by echocardiogram pre- and post-intervention
|
4 weeks
|
Blood pressure
Time Frame: 4 weeks
|
Changes in measures of central and brachial blood pressure (mmHg) at pre- and post-intervention
|
4 weeks
|
Carotid-Femoral Pulse Wave Velocity
Time Frame: 4 weeks
|
Changes in arterial stiffness as measured by carotid-femoral pulse wave velocity (m/s) at pre- and post-intervention
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4 weeks
|
Body Composition
Time Frame: 4 weeks
|
Changes in lean and fat mass (grams) will be measured via dual-energy x-ray absorptiometry pre-and post-intervention
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4 weeks
|
Physical Activity Enjoyment Scale
Time Frame: Immediately after the intervention
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Subject enjoyment of exercise will be measured using the Physical Activity Enjoyment Scale.
This is an 18 item questionnaire which assess how subjects feel about the exercise they have been performing.
Questions are scored using a 7-point likert scale
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Immediately after the intervention
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Minnesota Living with Heart Failure Questionnaire
Time Frame: 4 weeks
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Disease specific quality of life will be measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). he MLHFQ consists of 21 items that assess physical and emotional domains.
Each item/question is scored on a 0-5 Likert scale.
|
4 weeks
|
Epworth Sleepiness Questionnaire
Time Frame: 4 weeks
|
The Epworth sleepiness questionnaire is an 8 item questionnaire that measures how likely someone would be to fall asleep in 8 different scenarios.
Each item is graded on a 4 point likert scale ranging from "would never nod off" to "high chance of nodding off".
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4 weeks
|
Pittsburgh Sleep Quality Index
Time Frame: 4 weeks
|
Sleep quality and sleep disturbances over the pervious month will be measured with the Pittsburgh sleep quality index (PSQI).
The PSQI include 19 item self directed questions which look at a measures of sleep quality and a disturbances.
It also includes 5 questions to be answered by a roommate (if available) regarding the patients sleep habits.
|
4 weeks
|
Circadian Type Questionnaire
Time Frame: 4 weeks
|
The Circadian Type Questionnaire is an 19 item VAS that is used to assess someones ability to change their sleeping habits.
|
4 weeks
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Sleep Apnea
Time Frame: 4 weeks
|
Changes in sleep apnea will be measured using a WatchPAT device.
This device measured finger peripheral arterial tone and measures arterial volume changes in the finger.
This reflect changes in sympathetic tone and is associated with sleep disordered breathing.
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4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NTproBNP
Time Frame: 4 weeks
|
Assess changes in NTproBNP (pg/ml) as a biomarker of myocardial strain at pre- and post-intervention
|
4 weeks
|
Inflammation
Time Frame: 4 weeks
|
C-reactive protein (mg/dl) will be used as a biomarker for inflammation to be measured pre- and post-intervention
|
4 weeks
|
Lipids
Time Frame: 4 weeks
|
A lipid panel will be performed to measure total cholesterol, triglycerides, high-density lipoproteins, and low-density lipoprotein (mg/dl) to assess changes in cardiometabolic health pre- and post-intervention
|
4 weeks
|
Insulin
Time Frame: 4 weeks
|
Fasting insulin levels (U/ml) will be tested to assess changes in cardiometabolic health pre- and post-intervention
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4 weeks
|
Fasting Blood Glucose
Time Frame: 4 weeks
|
Fasting blood glucose levels (mg/dl) will be tested to assess changes in cardiometabolic health pre- and post-intervention
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4 weeks
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Endothelin-1
Time Frame: 4 weeks
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Arterial vasoconstrictor tone will be assessed by serum endothelin-1 (pg/mL) at pre- and post-intervention.
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4 weeks
|
Lipopolysaccharide
Time Frame: 4 weeks
|
Gut mucosal health and inflammation as measured by plasma Lipopolysaccharides (ng/mL) pre- and post-intervention
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4 weeks
|
Trimethylamine-N-oxide
Time Frame: 4 weeks
|
Trimethylamine-N-oxide (µM) will be used to assess gut mucosal health and inflammation pre- and post-intervention
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Siddhartha S Angadi, PhD, University of Virginia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSR210393
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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