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

NCT06296862 | Not Yet Recruiting

• 1 other identifier: STUDY00005563
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• B-natriuretic peptide (BNP)

  Clinically relevant natriuretic peptide

  Study visit 1-4

Secondary Outcomes (2)

• N-terminal-proBNP (NT-proBNP)

  Study visit 1-4

• Systolic and Diastolic Pulmonary Artery Pressures

  Patient-driven measurement data points during intervention/control phase (8 weeks)

Study Arms (2)

Dietary Approaches to Stop Hypertension Diet

EXPERIMENTAL

Other: Dietary Approaches to Stop Hypertension Diet

Usual Diet

NO INTERVENTION

Interventions

Dietary Approaches to Stop Hypertension Diet 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.

Dietary Approaches to Stop Hypertension Diet

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Georgia: lead
• Emory University: collaborator

Study Sites (1)

Emory Clinical Cardiovascular Research Center (ECCRI)

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Elisabeth LP Sattler, PhD, RPh

CONTACT

706-542-1040; lilian@uga.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: March 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)