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Rehabilitation Program in Heart Failure With Preserved Ejection Fraction

Primary Purpose

Heart Failure

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Cardiac Rehabilitation

Internal Medicine

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Rehabilitation, Heart failure, HFPEF, Exercise training

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

Sheba medical CenterRecruiting
Sheba Medical Center, Cardiac Rehabilitation Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cardiac Rehabilitation

Internal Medicine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Combined primary endpoint

Combined all-cause mortality and hospitalizations at a 12-months follow-up

Secondary Outcome Measures

Secondary endpoint - change in functional capacity and clinical status

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

Heart failure hospitalizations

Number of HF hospitalizations as assessed by HF specialists blinded to patients allocation. Assessment will include medical record and hospital discharge letter review.

Full Information

NCT ID

NCT01914315

First Posted

July 30, 2013

Last Updated

November 17, 2014

Sponsor

Sheba Medical Center

Collaborators

The Gertner Institute

1. Study Identification

Unique Protocol Identification Number

NCT01914315

Brief Title

Rehabilitation Program in Heart Failure With Preserved Ejection Fraction

Official Title

Multi-Disciplinary Rehabilitation Program in Recently Hospitalized Patients With Preserved Ejection Fraction Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

January 2016 (Anticipated)

Study Completion Date

June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sheba Medical Center

Collaborators

The Gertner Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Rehabilitation, Heart failure, HFPEF, Exercise training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cardiac Rehabilitation

Arm Type

Experimental

Arm Description

Arm Title

Internal Medicine

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Cardiac Rehabilitation

Other Intervention Name(s)

Exercise Training, Multi-disciplinary cardiac rehabilitation program

Intervention Description

Patients will participate in a 6-month cardiac rehabilitation program, consisting of structured, 60-minutes, bi-weekly exercise training sessions according to a predefined protocol. Institutional activity will be complemented by 120 minutes weekly home exercise prescribed by specialist in cardiac rehabilitation. Exercise prescription will be based on a symptom limited exercise test when clinically feasible and according with the patients' functional capacity, medical history and physiological values obtained prior to exercise. Target heart rate will be set initial as 50-60% of heart rate reserve and gradually increased up to 80% of HRR. Aerobic exercise will be complemented by resistance training of low intensity.

Intervention Type

Other

Intervention Name(s)

Internal Medicine

Intervention Description

Following discharge, patients will return to the 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. Target values for blood pressure and glucose control will be in accordance with current guidelines and special emphasis given to management of fluid retention.

Primary Outcome Measure Information:

Title

Combined primary endpoint

Description

Combined all-cause mortality and hospitalizations at a 12-months follow-up

Time Frame

12 months following randomization

Secondary Outcome Measure Information:

Title

Secondary endpoint - change in functional capacity and clinical status

Description

Time Frame

3 and 6 month follow-up after randomization

Title

All cause mortality end-point

Time Frame

12 months after randomization

Title

Heart failure hospitalizations

Description

Number of HF hospitalizations as assessed by HF specialists blinded to patients allocation. Assessment will include medical record and hospital discharge letter review.

Time Frame

12 months after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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

Facility Information:

Facility Name

Sheba medical Center

City

Ramat Gan

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nava Levine Tiefenbrun, Dr.

Nava.LevineTiefenbrun@sheba.health.gov.il

Facility Name

Sheba Medical Center, Cardiac Rehabilitation Institute

City

Tel Hashomer , Ramat Gan

Country

Israel

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Klempfner, MD

Phone

+972525506852

klempfner@gmail.com

First Name & Middle Initial & Last Name & Degree

Merav Moreno, Msc

Merav.Moreno@sheba.health.gov.il

First Name & Middle Initial & Last Name & Degree

Robert Klempfner, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

22726401

Citation

Stankovic I, Neskovic AN, Putnikovic B, Apostolovic S, Lainscak M, Edelmann F, Doehner W, Gelbrich G, Inkrot S, Rau T, Herrmann-Lingen C, Anker SD, Dungen HD. Sinus rhythm versus atrial fibrillation in elderly patients with chronic heart failure--insight from the Cardiac Insufficiency Bisoprolol Study in Elderly. Int J Cardiol. 2012 Nov 29;161(3):160-5. doi: 10.1016/j.ijcard.2012.06.004. Epub 2012 Jun 21.

Results Reference

background

PubMed Identifier

22615345

Citation

Steinberg BA, Zhao X, Heidenreich PA, Peterson ED, Bhatt DL, Cannon CP, Hernandez AF, Fonarow GC; Get With the Guidelines Scientific Advisory Committee and Investigators. Trends in patients hospitalized with heart failure and preserved left ventricular ejection fraction: prevalence, therapies, and outcomes. Circulation. 2012 Jul 3;126(1):65-75. doi: 10.1161/CIRCULATIONAHA.111.080770. Epub 2012 May 21.

Results Reference

background

PubMed Identifier

17491212

Citation

Lewis BS, Shotan A, Gottlieb S, Behar S, Halon DA, Boyko V, Leor J, Grossman E, Zimlichman R, Porath A, Mittelman M, Caspi A, Garty M; HFSIS Investigators. Late mortality and determinants in patients with heart failure and preserved systolic left ventricular function: the Israel Nationwide Heart Failure Survey. Isr Med Assoc J. 2007 Apr;9(4):234-8.

Results Reference

background

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Rehabilitation Program in Heart Failure With Preserved Ejection Fraction

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