Geriatric Out of Hospital Randomized Meal Trial in Heart Failure

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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

Key facts

Study ID

NCT02148679

Run by

University of Michigan

People needed

107

Starts

2014-05-01

Expected to finish

2017-07-01

Last updated by the study team

2017-07-27

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ann Arbor Veterans Affairs Health System — Ann Arbor, Michigan, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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