Geriatric Out of Hospital Randomized Meal Trial in Heart Failure (GOURMET-HF)
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About
Study subjects will receive either pre-prepared, home-delivered DASH/SRD-compliant meals or attention control for 4 weeks after hospital discharge.
Full description
This is a three center, randomized, single-blind, attention controlled trial of 12 weeks total duration designed to determine the safety and efficacy of home-delivered sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD)-compliant meals in older adults (age >= 65 years) following discharge from a hospital admission for acutely decompensated heart failure. 66 subjects will be randomized in a 1:1 stratified fashion by gender and left ventricular ejection fraction (< vs. ≥ 50%).
107 subjects yielded 66 randomized subjects.
Study subjects will receive either pre-prepared, home-delivered DASH/SRD-compliant meals or attention control for 4 weeks after hospital discharge. The three study sites will be Columbia University Medical Center, the Ann Arbor Veterans Affairs Health System, and the University of Michigan Health System. Investigators will be blinded to group assignment, food diaries, and urinary electrolyte measurements until the completion of the study
Enrollment
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Volunteers
Inclusion criteria
66 male and female patients aged ≥ 55 years with history of systemic hypertension and acutely decompensated heart failure (ADHF; primary diagnosis for admission or secondary diagnosis after hospitalization for another reason). ADHF will be confirmed by the study physician and defined as a combination of symptoms, signs, and HF-specific medical treatments. Specifically, ADHF will require that all four of the following conditions are met:
- ≥1 symptom of HF (dyspnea, fatigue, orthopnea, paroxysmal nocturnal dyspnea) has worsened from baseline
- ≥ 2 signs of HF (pulmonary congestion on exam and/or chest X-ray, elevated jugular venous pressure, peripheral edema or rapid weight gain, and/or increased B-type natriuretic peptide (BNP; ≥100 pg/ml)
- change in medical treatment specifically targeting HF (diuretics, vasodilators, and/or neurohormonal modulating agents)
- no other cause of the patient's symptoms and signs is apparent
Exclusion criteria
- persistent hypotension during hospitalization or excessive risk of hypotension from the study diet as judged by the investigators or systolic BP <110 on discharge
- use of inotropic therapy at hospital discharge,
- severe valvular heart disease as the primary etiology of the patient's HF syndrome
- uncontrolled hypertension defined as the following criteria for the last 24 hours prior to discharge (systolic BP >180 mmHg or diastolic BP >100 mmHg)
- having two or more results of a serum potassium >5.0 mmol/L during hospitalization or history of serum potassium >6.0 mmol/L, and/or at an excessive risk of hyperkalemia as judged by the investigators
- severe renal insufficiency (estimated glomerular filtration rate <30 ml/min/1.73m^2 at discharge)
- severe anemia (hemoglobin < 9 gm/dl)
- length of stay <48 hours or >14 days
- co-morbidity with expected survival < 12 months
- active alcohol or substance abuse
- history of persistent noncompliance with treatment recommendations as judged by the investigators
Trial design
Primary purpose
Allocation
Interventional model
Masking
107 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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