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

NCT05236413 | Recruiting DMC

• 1 other identifier: HSR210393
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

HIIT; DASH; High Fiber; HFpEF; heart failure

Outcome Measures

Primary Outcomes (1)

• VO2peak

  Change in VO2peak (L/min) measured pre- and post-intervention

  4 weeks

Secondary Outcomes (12)

• Diastolic Function

  4 weeks

• Ejection Fraction

  4 weeks

• Global Longitudinal Strain

  4 weeks

• Blood pressure

  4 weeks

• Carotid-Femoral Pulse Wave Velocity

  4 weeks

Other Outcomes (8)

• NTproBNP

  4 weeks

• Inflammation

  4 weeks

• Lipids

  4 weeks

Study Arms (3)

High Intensity Interval Exercise

EXPERIMENTAL

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

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.

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.

Behavioral: Exercise + DASH Diet

Interventions

High Intensity Interval Exercise BEHAVIORAL

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.

High Intensity Interval Exercise

Dietary Approaches to Stop Hypertension (DASH) Diet BEHAVIORAL

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.

Dietary Approaches to Stop Hypertension (DASH) Diet

Exercise + DASH Diet BEHAVIORAL

Patients will undergo both the exercise training intervention and DASH diet as explained above.

Exercise + DASH Diet

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• Grain Foods Foundation: collaborator

Study Sites (1)

University of Virginia University Hospital

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

High-Intensity Interval Training; Dietary Approaches To Stop Hypertension; Diet; Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Siddhartha S Angadi, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siddhartha S Angadi, PhD

CONTACT

434-243-7466; ssa2w@virginia.edu

Nathan Weeldreyer, MS

CONTACT

434-243-8677; nw8ky@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blinded to group allocations. Subjects will know which group they have been randomized to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, blinded, 3-arm parallel-group design

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 11, 2022
• Study Start: April 1, 2022
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)