Heart Failure Clinical Trial
Official title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory Clinical Cardiovascular Research Center (ECCRI) | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
University of Georgia | Emory University |
United States,
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) |
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