Status:
UNKNOWN
Rehabilitation Program in Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
Sheba Medical Center
Collaborating Sponsors:
The Gertner Institute
Conditions:
Heart Failure
Eligibility:
All Genders
21+ years
Phase:
NA
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 preserve...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT01914315
Start Date
October 1 2013
End Date
June 1 2016
Last Update
November 18 2014
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Sheba medical Center
Ramat Gan, Israel
2
Sheba Medical Center, Cardiac Rehabilitation Institute
Tel Hashomer , Ramat Gan, Israel