NCT01914315

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

2.3 years

First QC Date

July 30, 2013

Last Update Submit

November 17, 2014

Conditions

Heart Failure

Keywords

RehabilitationHeart failureHFPEFExercise training

Outcome Measures

Primary Outcomes (1)

  • Combined primary endpoint

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

    12 months following randomization

Secondary Outcomes (3)

  • 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

Study Arms (2)

Cardiac Rehabilitation

EXPERIMENTAL

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.

Behavioral: Cardiac Rehabilitation

Internal Medicine

ACTIVE COMPARATOR

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.

Other: Internal Medicine

Interventions

Cardiac RehabilitationBEHAVIORAL

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.

Also known as: Exercise Training, Multi-disciplinary cardiac rehabilitation program
Cardiac Rehabilitation
Internal MedicineOTHER

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.

Internal Medicine

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sheba medical Center

Ramat Gan, Israel

RECRUITING

Sheba Medical Center, Cardiac Rehabilitation Institute

Tel Hashomer , Ramat Gan, Israel

NOT YET RECRUITING

Related Publications (3)

  • 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.

    PMID: 22726401BACKGROUND

  • 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.

    PMID: 22615345BACKGROUND

  • 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.

    PMID: 17491212BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac RehabilitationExercise

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Cardiac Rehabilitation Institute

Study Record Dates

First Submitted

July 30, 2013

First Posted

August 2, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

IL(2)