Effects of Home-delivered Low-sodium Meals in Older Adults Following Heart Failure Hospitalization.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 5
- 主要终点
- change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary scores for health-related QOL in patients with chronic HF
研究概览
简要总结
Study subjects will receive either pre-prepared, home-delivered DASH/SRD-compliant meals or attention control for 4 weeks after hospital discharge.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
DASH/SRD
Patients receive Heart Failure Society of America pamphlet, "How to eat a low sodium diet" at hospital discharge
Study staff will phone patients at weeks 2 and 3 to confirm patients' understanding of dietary instructions
Intervention: pre-prepared, home delivered DASH/SRD-compliant meals for 4 weeks after hospital discharge
干预措施: DASH/SRD (Other)
Attention Control
Patients receive Heart Failure Society of America pamphlet, "How to eat a low sodium diet" at hospital discharge
Study staff will phone patients at weeks 2 and 3 to confirm patients' understanding of dietary instructions
干预措施: DASH/SRD (Other)
Attention Control
Patients receive Heart Failure Society of America pamphlet, "How to eat a low sodium diet" at hospital discharge
Study staff will phone patients at weeks 2 and 3 to confirm patients' understanding of dietary instructions
干预措施: Usual care (Other)
结局指标
主要结局
change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary scores for health-related QOL in patients with chronic HF
时间窗: from study enrollment to 4 weeks post-discharge
The KCCQ, a self-administered 23-item instrument, assesses physical limitations, symptoms, self-efficacy, social interference, and overall QOL in HF patients. The KCCQ summary score ranges from 0-100, with higher scores indicating better QOL. The KCCQ summary score independently predicts clinical outcomes such as hospitalization and mortality in outpatients with HF, including those recently hospitalized for acute decompensation. It is a reliable and valid measure in HF patients that is more sensitive to change than other measures of QOL, and is especially responsive in patients with multiple comorbidities. A change in KCCQ score of 5 points is clinically significant and correlates with changes in clinical status, physical function, and outcomes.
次要结局
- Safety Monitoring(Baseline and 1 week post discharge)
- Dietary Endpoints(baseline, 4 weeks)
- Mechanism-related endpoints(Baseline to 4 weeks)
研究者
Scott L. Hummel
Assistant Professor
University of Michigan