Background
Heart Failure (HF) is a major public health problem affecting predominantly older adults. Non-adherence to diet remains a significant contributor to acute decompensated HF (ADHF). The sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan reduces cardiovascular dysfunction that can lead to ADHF and is consistent with current HF guidelines. We propose that an intervention that promotes adherence to the DASH/SRD by home-delivering meals will be safe and improve health-related quality of life (QOL) in older adults following hospitalization for ADHF.
Methods/Design
This is a three center, randomized, single-blind, controlled trial of 12 weeks duration designed to determine the safety and efficacy of home-delivered DASH/SRD-compliant meals in older adults following discharge from ADHF hospitalization. 66 subjects will be randomized in a 1:1 stratified fashion by gender and left ventricular ejection fraction (< vs. ≥50%). Study subjects will receive either pre-prepared, home-delivered DASH/SRD-compliant meals or usual dietary advice for 4 weeks after hospital discharge. Investigators will be blinded to group assignment, food diaries, and urinary electrolyte measurements until study completion. The primary efficacy endpoint is the change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary scores for health-related QOL from study enrollment to 4 weeks post-discharge. Safety evaluation will focus on hypotension, renal insufficiency, and hyperkalemia. Exploratory endpoints include echocardiography, non-invasive vascular testing, markers of oxidative stress, and salt taste sensitivity.
Conclusion
This randomized controlled trial will test the efficacy, feasibility and safety of 4 weeks of DASH/SRD after ADHF hospitalization. By testing a novel dietary intervention supported by multiple levels of evidence including preliminary data in outpatients with stable HF, we will address a critical evidence gap in the care of older patients with ADHF. If effective and safe, this intervention could be scaled to assess effects on readmission and healthcare costs in older adults following ADHF.