Geriatric Out of Hospital Randomized Meal Trial in Heart Failure

Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:65 - Any
Start Date:May 2014
End Date:December 2017

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Effects of Home-delivered Low-sodium Meals in Older Adults Following Heart Failure Hospitalization.

Study subjects will receive either pre-prepared, home-delivered DASH/SRD-compliant meals or
attention control for 4 weeks after hospital discharge.

This is a two 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. 60 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
attention control for 4 weeks after hospital discharge. The two study sites will be Columbia
University Medical Center 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

Inclusion Criteria:

60 male and female patients aged ≥ 65 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

- ≥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:

- systolic BP <100 mmHg at any time during hospitalization

- use of inotropic therapy, severe valvular heart disease as the primary etiology of
the patient's HF syndrome

- uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >100 mmHg) or
systolic BP <110 on discharge

- serum potassium >5.0 mmol/L during hospitalization or history of serum potassium >6.0

- severe renal insufficiency (estimated glomerular filtration rate <30 ml/min/1.73m2 at

- 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
We found this trial at
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Scott L Hummel, M.D., M.S.
Phone: 734-764-7440
University of Michigan The University of Michigan was founded in 1817 as one of the...
Ann Arbor, MI
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Mathew S Maurer, MD
Phone: 212-305-8274
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
New York, NY
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