Abstract| Volume 23, ISSUE 11, P830, November 2017

Geriatric Out-of-Hospital Randomized Meal Trial in Heart Failure (GOURMET-HF) Pilot Randomized Trial: Primary Results

      Introduction: In patients with heart failure (HF), malnutrition and excess dietary sodium intake are common and may worsen outcomes. However, some studies suggest no benefit or even harm related to dietary sodium restriction in HF. No previous studies have examined the effects of providing low-sodium, nutritionally-complete meals following discharge from HF hospitalization. Hypothesis and Outcomes: Compared with usual care, home meal delivery of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating pattern will improve HF-related quality of life at 4 weeks post-discharge from HF hospitalization. In addition to safety monitoring and clinical event reporting, additional data collected in the study include changes in cardiac and inflammatory biomarkers, cardiac and vascular function, micronutrient levels, and salt taste affinity. Methods: GOURMET-HF is a three-site, single-blind, randomized controlled pilot trial (NCT02148679) in patients admitted for acutely decompensated HF with previous history of hypertension. Participants were randomized at hospital discharge to home-delivered DASH/SRD (1500 mg sodium/day) vs. usual care. The primary study outcome is the between-group change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score from baseline to 4 weeks post-discharge. The main exclusion criteria were symptomatic hypotension, hyperkalemia, and severe renal insufficiency (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73 m2). Key clinical outcomes include death/all-cause readmission and potential diet-related adverse events (symptomatic hypotension, hyperkalemia, acute kidney injury). Additional outcomes include change in KCCQ sub-domains, including the Clinical Summary Score (average of Physical Limitation and Total Symptom scores), and general quality of life (SF-12, Visual Analog Scale). Paired t-testing was used for within-group and ANCOVA, 2-sample t-testing, chi-square, or Fisher's exact test were used as appropriate for between-group comparisons. Results: Of 107 enrolled participants, 66 met criteria at hospital discharge and were randomized 1:1 to DASH/SRD vs. usual care (age 71 ± 8 years, 30% female, 30% African-American, 36% Hispanic, 56% diabetes mellitus, body mass index 32.6 ± 7.7 kg/m2, ejection fraction 39 ± 18%, eGFR 54 ± 17). The HF-related quality of life increased in both groups at 4 weeks; general quality of life did not change. The change in KCCQ Summary Score did not differ between groups, but KCCQ Clinical Summary Score improved to a greater degree in the DASH/SRD group (Figure). Potentially diet-related adverse events were numerically more common, but 30-day readmissions and days hospitalized trended lower in the DASH/SRD group (Table). Conclusions: Home-delivered DASH/SRD immediately following HF hospitalization appeared safe in selected patients, and had directionally favorable effects on HF clinical status and 30-day readmissions. Larger studies are warranted to determine the effects of post-discharge dietary support on functional status and readmission rate in patients with HF.
      FigureKCCQ Summary and Clinical Summary Scores
      TableKey study outcomes
      Table thumbnail yjcaf4061-fig-5001
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