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

Effect of Dietary Approaches to Stop Hypertension Diet on Heart Failure Status in Older Adults

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Dietary Approaches to Stop Hypertension Diet

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabeth LP Sattler, PhD, RPh; Phone Number: 706-542-1040; Email: lilian@uga.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Clinical Cardiovascular Research Center (ECCRI)
      • Contact: Arshed A Quyyumi, MD, PhD; Phone Number: 404-727-6635; Email: quyyum@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary Approaches to Stop Hypertension Diet	Other: 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.
No Intervention: Usual Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
B-natriuretic peptide (BNP)	Clinically relevant natriuretic peptide	Study visit 1-4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
N-terminal-proBNP (NT-proBNP)	Clinically relevant natriuretic peptide	Study visit 1-4
Systolic and Diastolic Pulmonary Artery Pressures	Early indicator of heart failure complications	Patient-driven measurement data points during intervention/control phase (8 weeks)

Collaborators and Investigators

• Sponsor: University of Georgia
• Collaborators: Emory University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Estimated): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: STUDY00005563

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No