Heart Failure With Preserved Ejection FractionNCT05236413
The Effect of a High Fiber Diet and High-Intensity Interval Exercise in Patients With HFpEF
A study testing High Intensity Interval Exercise, Dietary Approaches to Stop Hypertension (DASH) Diet and Exercise + DASH Diet in people with Heart Failure With Preserved Ejection Fraction, run by University of Virginia at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- High Intensity Interval Exercise, Dietary Approaches to Stop Hypertension (DASH) Diet and Exercise + DASH Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia University Hospital
Charlottesville, Virginia, 22903
Siddhartha S Angadi, PhD, ssa2w@virginia.edu
Nathan Weeldreyer, MS, 434-243-8677, nw8ky@virginia.edu
About this study
Official title: The Effect of a High Fiber Diet and High-Intensity Interval Exercise in Patients With Heart Failure With Preserved Ejection Fraction
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.
Read the 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.
- Being tested
- High Intensity Interval Exercise, Dietary Approaches to Stop Hypertension (DASH) Diet, Exercise + DASH Diet
- Keywords
- HIIT, DASH, High Fiber, HFpEF, heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval ExerciseBehavioural
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.
Dietary Approaches to Stop Hypertension (DASH) DietBehavioural
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.
Exercise + DASH DietBehavioural
Patients will undergo both the exercise training intervention and DASH diet as explained above.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Exercise | Experimental | Enrolled patients will perform supervised exercise on 3 nonconsecutive days of the week for 4 weeks. Receives: Behavioral: High Intensity Interval Exercise |
| Dietary Approaches to Stop Hypertension (DASH) Diet | Experimental | 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. Receives: Behavioral: Dietary Approaches to Stop Hypertension (DASH) Diet |
| Exercise + DASH Diet | Experimental | Enrolled subjects will undergo both the exercise training visits and be provided with the DASH diet. Receives: Behavioral: Exercise + DASH Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2peak
Change in VO2peak (L/min) measured pre- and post-intervention
Measured: 4 weeks
Secondary outcomes (12)
Diastolic Function
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
Measured: 4 weeks
Ejection Fraction
Ejection fraction (%) will be used to assess changes in cardiac contractile function and be measured by echocardiogram pre- and post-intervention
Measured: 4 weeks
Global Longitudinal Strain
Global longitudinal strain (%) will be used to assess changes in cardiac contractile function and be measured by echocardiogram pre- and post-intervention
Measured: 4 weeks
Blood pressure
Changes in measures of central and brachial blood pressure (mmHg) at pre- and post-intervention
Measured: 4 weeks
Carotid-Femoral Pulse Wave Velocity
Changes in arterial stiffness as measured by carotid-femoral pulse wave velocity (m/s) at pre- and post-intervention
Measured: 4 weeks
Body Composition
Changes in lean and fat mass (grams) will be measured via dual-energy x-ray absorptiometry pre-and post-intervention
Measured: 4 weeks
Physical Activity Enjoyment Scale
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
Measured: Immediately after the intervention
Minnesota Living with Heart Failure Questionnaire
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.
Measured: 4 weeks
Epworth Sleepiness Questionnaire
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".
Measured: 4 weeks
Pittsburgh Sleep Quality Index
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.
Measured: 4 weeks
Circadian Type Questionnaire
The Circadian Type Questionnaire is an 19 item VAS that is used to assess someones ability to change their sleeping habits.
Measured: 4 weeks
Sleep Apnea
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Apr 2022
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, blinded, 3-arm parallel-group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Grain Foods Foundation
- Responsible party
- Principal investigator, Siddartha Angadi, University of Virginia
- Investigators
- Siddhartha S Angadi, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236413
- Sponsor's protocol ID
- HSR210393
- Status last verified
- May 2024
- First submitted
- 31 Jan 2022
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data will be shared on request.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a High Fiber Diet and High-Intensity Interval Exercise in Patients With Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT05236413
- Acronym / sponsor ID
- HSR210393
- Keywords
- HIIT, DASH, High Fiber, HFpEF, heart failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Grain Foods Foundation
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, blinded, 3-arm parallel-group design
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Exercise | Experimental | Behavioral: High Intensity Interval ExerciseEnrolled patients will perform supervised exercise on 3 nonconsecutive days of the week for 4 weeks. |
| Dietary Approaches to Stop Hypertension (DASH) Diet | Experimental | Behavioral: Dietary Approaches to Stop Hypertension (DASH) DietEnrolled 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. |
| Exercise + DASH Diet | Experimental | Behavioral: Exercise + DASH DietEnrolled subjects will undergo both the exercise training visits and be provided with the DASH diet. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (14 listed)
- Unstable angina
- Myocardial infarction in the past 4 weeks
- Uncompensated heart failure
- NYHA class IV symptoms
- Complex ventricular arrhythmias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval ExercisePatients 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. | Behavioural | High Intensity Interval Exercise |
| Dietary Approaches to Stop Hypertension (DASH) DietPatients 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. | Behavioural | Dietary Approaches to Stop Hypertension (DASH) Diet |
| Exercise + DASH DietPatients will undergo both the exercise training intervention and DASH diet as explained above. | Behavioural | Exercise + DASH Diet |
Primary outcome
VO2peak
Time frame: 4 weeks
Change in VO2peak (L/min) measured pre- and post-intervention
12 secondary outcomes
Diastolic Function
Time frame: 4 weeks
Ejection Fraction
Time frame: 4 weeks
Global Longitudinal Strain
Time frame: 4 weeks
Blood pressure
Time frame: 4 weeks
Carotid-Femoral Pulse Wave Velocity
Time frame: 4 weeks
Body Composition
Time frame: 4 weeks
Physical Activity Enjoyment Scale
Time frame: Immediately after the intervention
Minnesota Living with Heart Failure Questionnaire
Time frame: 4 weeks
Epworth Sleepiness Questionnaire
Time frame: 4 weeks
Pittsburgh Sleep Quality Index
Time frame: 4 weeks
Circadian Type Questionnaire
Time frame: 4 weeks
Sleep Apnea
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No. Deidentified data will be shared on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siddhartha S Angadi, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Exercise, Dietary Approaches to Stop Hypertension (DASH) Diet and Exercise + DASH Diet in people with Heart Failure With Preserved Ejection Fraction, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siddhartha S Angadi, PhD (434-243-7466, ssa2w@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2peak (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.