Multi-Disciplinary Rehabilitation Program in Recently Hospitalized Patients With Preserved Ejection Fraction Heart Failure
试验速览
- 阶段
- 不适用
- 入组人数
- 1,100
- 试验地点
- 2
- 主要终点
- Combined primary endpoint
研究概览
简要总结
The purpose of this prospective study is to determine whether comprehensive cardiac rehabilitation is superior to usual disease management in the treatment of patients with heart failure with preserved systolic function (HFpEF) recently discharged after an acute heart failure event.
The investigators hypothesize that the addition of bi-weekly structured exercise training and interaction with medical personnel will lead to a greater reduction in all cause hospitalization and mortality while providing additional functional and clinical benefits such as exercise capacity, quality of life and well-being.
Furthermore the investigators seek to establish clinical, laboratory and echocardiographic predictors of hospital readmissions and cardiovascular events in the predefined HFpEF population.
详细描述
Our primary objective is to test the hypothesis that comprehensive multi-disciplinary cardiac rehabilitation program is superior to usual care in the treatment of patients with HFpEF discharged after an acute heart failure event, and will result in a 25% reduction in the composite outcome of all cause hospitalizations and all-cause mortality after 1-year of follow-up. This objective represents both safety and efficacy end-point in a patient population with a high rate of co-morbidities, which may be affected as well. Previous observation has shown that these patients have a high rate of non-cardiac death in comparison with HFrEF, thus enhancing the importance of all-cause hospitalization and mortality as a primary end-point.
Secondary end-points that will be recorded include separate components of the primary end-point, time to first hospitalization, functional capacity measured by NYHA class, 6-minute walk test (6MWT), blood pressure during rest and exercise, fasting glucose and Hb A1C levels, BNP values and quality of life EQ5-D questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >=21 years of age willing and able to sign consent forms
- •Hospitalization for acute heart failure (AHF) in one of the internal medicine departments participating in the study
- •AHF as the primary diagnosis as defined by:
- •(I) The presence of pulmonary congestion or edema on chest radiography OR
- •(II) Evidence of fluid retention (pedal edema, pleural effusion, ascites) not otherwise explained by other conditions (i.e. malignancy, nephrotic syndrome, liver cirrhosis, severe hypo-albuminemia, etc) AND
- •(III) Echocardiography demonstrating the presence of preserved systolic function
- •In cases where diagnosis is unclear BNP testing (with a cutoff value of >300 ng/dl) will be used.
- •If there is clinical suspicion of pulmonary disease investigators are encouraged to perform pulmonary function tests after the patient condition is stabilized.
- •Preserved systolic function as determined by in-hospital or recent (within 3 months) echocardiographic examination according to ESC guidelines and in the absence of hemodynamic significant valvular disease.
- •Stable clinical condition prior to discharge permitting the initiation of an exercise training program
排除标准
- •Hemodynamically significant valvular disease (severity > mild other than TR)
- •Acute coronary syndrome as the primary diagnosis
- •End stage heart failure - NYHA IV
- •Severe renal dysfunction - eGFR<30 ml/min/1.73m2 or renal replacement therapy
- •Inability to participate in an exercise program and comply with study protocol
- •Severe chronic obstructive pulmonary disease (COPD) (FEV1<50%) or asthma defined as severe
- •First episode of a hypertensive crisis event (without history of chronic heart failure)
- •Cognitive decline or major psychiatric pathology
- •Non ambulatory condition
- •Life expectancy < 12 months
- •Substance dependency
- •Inability to participate due to technical barriers such as a significant distance from a cardiac rehabilitation center
结局指标
主要结局
Combined primary endpoint
时间窗: 12 months following randomization
Combined all-cause mortality and hospitalizations at a 12-months follow-up
次要结局
- Secondary endpoint - change in functional capacity and clinical status(3 and 6 month follow-up after randomization)
- All cause mortality end-point(12 months after randomization)
- Heart failure hospitalizations(12 months after randomization)
研究者
Dr. Robert Klempfner Heart Rehabilitation Institute
Director Cardiac Rehabilitation Institute
Sheba Medical Center