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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06296862
• Other study ID #: STUDY00005563
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: University of Georgia
• Contact: Elisabeth LP Sattler, PhD, RPh
• Phone: 706-542-1040
• Email: lilian[@]uga.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Emory Clinical Cardiovascular Research Center (ECCRI)	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
University of Georgia	Emory University

Country where clinical trial is conducted

United States, 

Outcome

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