Effect of DASH on HF Outcomes Heart Failure Status in Older Adults (DASH HF)

NCT ID: NCT06296862

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2025-06-30

Brief Summary

The purpose of this study is to examine the effect of the Dietary Approaches to Stop Hypertension (DASH) diet has on heart failure status in older adults. This study is important because it may provide a low-cost strategy to help reduce hospitalizations and deaths for heart failure patients. Participants will be adults age 65 and older with heart failure. They will have 4 study visits, each lasting about 2 hours, and will be in the study for 12 weeks. They will also be asked about their dietary consumption 6 times, each time lasting about 45 minutes. All in-person study visits will take place in the Emory GCRC. Participants will have physical exams, body measurements, blood tests, urinalysis, chart review, and answer surveys. They will be randomized to eat only the DASH diet provided to them for 4 weeks either at the beginning or end of their participation in the study. Participants will be recruited from heart failure patients at Emory University Hospital, Emory University Hospital Midtown, and Emory Outpatient Advanced Heart Failure Therapy Center. The total enrollment planned under Emory's oversight, accounting for screen failures and withdrawals, will be n=38 participants. The study team will obtain informed consent prior to the first study visit either in person, or, alternatively, over the phone, if requested by participants. Specimens and data obtained in this study will not be banked for future use.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dietary Approaches to Stop Hypertension Diet

Group Type: EXPERIMENTAL

Dietary Approaches to Stop Hypertension Diet

Intervention Type: OTHER

The DASH diet is a heart-healthy eating pattern that is focused on adequate consumption of fruits, vegetables, whole grains, low-fat dairy, fish, poultry, beans, nuts, and vegetables oils while emphasizing limited intake of foods containing saturated fat, such as fatty red meats, full-fat dairy products, and tropical oils, such as coconut, palm kernel, and palm oils, as well as sugar-sweetened beverages and sweets. The chosen 4 week intervention duration phase is consistent with previous research showing positive effects of consuming a sodium-reduced dietary intervention on volume status and is longer than in other studies showing positive effects of DASH diet consumption on cardiac outcomes among HF patients. Potential carryover effects are minimized by a washout period of 4 weeks. The meal plan has been previously developed based on NHLBI guidelines for the DASH diet.

Usual Diet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dietary Approaches to Stop Hypertension Diet

The DASH diet is a heart-healthy eating pattern that is focused on adequate consumption of fruits, vegetables, whole grains, low-fat dairy, fish, poultry, beans, nuts, and vegetables oils while emphasizing limited intake of foods containing saturated fat, such as fatty red meats, full-fat dairy products, and tropical oils, such as coconut, palm kernel, and palm oils, as well as sugar-sweetened beverages and sweets. The chosen 4 week intervention duration phase is consistent with previous research showing positive effects of consuming a sodium-reduced dietary intervention on volume status and is longer than in other studies showing positive effects of DASH diet consumption on cardiac outcomes among HF patients. Potential carryover effects are minimized by a washout period of 4 weeks. The meal plan has been previously developed based on NHLBI guidelines for the DASH diet.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 65+ years of age
• Heart failure diagnosis and symptoms, as outlined by the 2021 European Society of Cardiology diagnostic guidelines
• Residence within 50 miles of Emory University
• Have undergone hemodynamic monitoring device implantation (CardioMEMS, Abbott)
• Have received optimized HF therapy for 3+ months post CardioMEMS implantation

Exclusion Criteria

• Heart failure-related hospitalization or heart failure medication changes within 1 month
• Renal disease stages IV-V
• Expected survival < 12 months
• Dementia or Alzheimer's disease
• Limited English literacy and communication skills

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

University of Georgia

OTHER

Sponsor Role: lead

Responsible Party

Elisabeth Lilian Pia Sattler, Ph.D., B.S. Pharm

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emory Clinical Cardiovascular Research Center (ECCRI)

Atlanta, Georgia, United States

Countries

United States

Central Contacts

Elisabeth LP Sattler, PhD, RPh

Role: CONTACT

lilian@uga.edu

706-542-1040

Facility Contacts

Arshed A Quyyumi, MD, PhD

Role: primary

quyyum@emory.edu

404-727-6635

Other Identifiers

STUDY00005563

Identifier Type: -

Identifier Source: org_study_id