Clinical trial NCT06296862: Effect of DASH on HF Outcomes Heart Failure Status in Older Adults (DASH HF)
Official title: Effect of Dietary Approaches to Stop Hypertension Diet on Heart Failure Status in Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Georgia
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2024-03-06
Enrollment: 38
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: B-natriuretic peptide (BNP)
timeFrame: Study visit 1-4
Secondary outcomes:
measure: N-terminal-proBNP (NT-proBNP)
timeFrame: Study visit 1-4
measure: Systolic and Diastolic Pulmonary Artery Pressures
timeFrame: Patient-driven measurement data points during intervention/control phase (8 weeks)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Clinical Cardiovascular Research Center (ECCRI)
state: Georgia
Study officials:
References: