Rehabilitation Program in Heart Failure With Preserved Ejection Fraction

Not Applicable

• Conditions: Heart Failure
• Interventions: Behavioral: Cardiac Rehabilitation; Other: Internal Medicine

• Registration Number: NCT01914315
• Lead Sponsor: Sheba Medical Center

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-02
• Study Start: 2013-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18
• Primary Completion: 2016-01
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiac Rehabilitation	Cardiac Rehabilitation	Patients randomized to the multidisciplinary cardiac management program at the cardiac rehabilitation center will undergo evaluation by a trained rehabilitation physician and physiologist. The evaluation will include medical history, physical examination, vitals, review of post discharge graded exercise stress test and nursing staff consultation. Exercise prescription will be based on a pre-specified protocol in accordance with ESC position paper on cardiac rehabilitation of patients with heart failure.
Internal Medicine	Internal Medicine	Following discharge, patients will return to the internal medicine (IM) outpatient clinics at 2-4 weeks, 3, and 6 months for consultation. These scheduled consultations will comprise of history taking, recording of any new events, physical examination and recommendations as clinically indicated.

Primary Outcome Measures

Name	Time	Method
Combined primary endpoint	12 months following randomization	Combined all-cause mortality and hospitalizations at a 12-months follow-up

Secondary Outcome Measures

Name	Time	Method
Secondary endpoint - change in functional capacity and clinical status	3 and 6 month follow-up after randomization	Secondary clinical outcomes will be collected during the 3 and 6 month follow-up visits and will include: blood pressure averages , HbA1C levels, assessment of NYHA class and global clinical assessment , 6-minute walk test and quality of life data as evaluated by the EQ-5D questionnaire
All cause mortality end-point	12 months after randomization
Heart failure hospitalizations	12 months after randomization	Number of HF hospitalizations as assessed by HF specialists blinded to patients allocation. Assessment will include medical record and hospital discharge letter review.

Trial Locations

Locations (2)

Sheba medical Center; 🇮🇱 Ramat Gan, Israel

Sheba Medical Center, Cardiac Rehabilitation Institute; 🇮🇱 Tel Hashomer , Ramat Gan, Israel