DASH Diet in Heart Failure Outpatients (DASH-HF)

University of California (UC) Davis

Status: Active, not recruiting

Conditions: Heart Failure

Treatments: Behavioral: DASH diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05117086

1770356

Details and patient eligibility

About

The purpose of this study is to refine the classification of the effectiveness of the DASH diet for outpatient heart failure (HF) management, using behavioral, clinical, and laboratory correlative science approaches.

Full description

The overall objective of this pilot study is to refine the classification of the effectiveness of the DASH diet for outpatient HF management using behavioral, clinical, and laboratory correlative science approaches. The investigators will integrate the use and evaluation of DASH diet nutrition education in a clinical population using a pragmatic study approach. The investigators will assess dietary behavior change. The investigators will assess the medical effectiveness of the DASH diet to improve patient symptomology and clinical biomarkers. Exploratory investigations will involve metabolomics analyses of plasma samples for biomarker discovery of clinical phenotypes in HF patients, to characterize metabolic profiles related to dietary exposure.

Enrollment: 26 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Heart Failure diagnosis
• Guideline directed medical therapy optimization on stable regimen at least 30 days

Exclusion criteria

• BMI < 18/5 kg/m squared
• cardiac cachexia
• end-stage renal disease or dialysis
• acute inflammatory condition
• uncontrolled arrhythmias or ischemia
• status post heart transplant or implanted left ventricular assist device

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Dietary Intervention Arm

Experimental group

Description:

Subjects will receive the active intervention of nutrition education and medical nutrition therapy counseling for dietary and behavioral lifestyle changes. The focus will be on DASH diet implementation and adherence for management of heart failure. The subjects will have 4 study visits with a Registered Dietitian over 6 months (visits at 1, 2, 3, and 6 months). Outcome measures will be assessed at baseline, 3 and 6 months.

Treatment:

Behavioral: DASH diet