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Heart FailureNCT01914315

Rehabilitation Program in Heart Failure With Preserved Ejection Fraction

A study testing Cardiac Rehabilitation and Internal Medicine in people with Heart Failure, run by Sheba Medical Center at 2 sites in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Heart Failure
What is being tested?
Cardiac Rehabilitation and Internal Medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,100 participants
Where
2 sitesIsrael
Study dates
Oct 2013to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Israel2 sites, 2 recruiting

  • Sheba medical Center

    Ramat Gan

    Nava Levine Tiefenbrun, Dr., Nava.LevineTiefenbrun@sheba.health.gov.il

    Recruiting

  • Sheba Medical Center, Cardiac Rehabilitation Institute

    Tel Hashomer , Ramat Gan

    Robert Klempfner, MD, +972525506852, klempfner@gmail.com

    Merav Moreno, Msc, Merav.Moreno@sheba.health.gov.il

    Not yet recruiting

Other trials in Israel

About this study

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

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.

Read the 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.

Conditions
Heart Failure
Being tested
Cardiac Rehabilitation, Internal Medicine
Keywords
Rehabilitation, Heart failure, HFPEF, Exercise training
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac RehabilitationBehavioural

    Also called Exercise Training, Multi-disciplinary cardiac rehabilitation program

    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.

  • 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.

Study groups in NCT01914315
Study groupRoleWhat they receive
Cardiac RehabilitationExperimentalPatients 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.
Receives: Behavioral: Cardiac Rehabilitation
Internal MedicineActive comparatorFollowing 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.
Receives: Other: Internal Medicine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined primary endpoint

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

    Measured: 12 months following randomization

Secondary outcomes (3)

  1. 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

    Measured: 3 and 6 month follow-up after randomization

  2. All cause mortality end-point

    Measured: 12 months after randomization

  3. 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.

    Measured: 12 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionJan 2016 (estimated)
  4. Study completionJun 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01914315
Sponsor's protocol ID
SHEBA-13-0246-RK-CTIL
Status last verified
Nov 2014
First submitted
30 Jul 2013
Last updated
18 Nov 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22726401

  • 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.

    PubMed 22615345

  • 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.

    PubMed 17491212

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac Rehabilitation and Internal Medicine in people with Heart Failure, run by Sheba Medical Center at 2 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined primary endpoint (time frame: 12 months following randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01914315, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014; AzTrials last refreshed its copy on 30 Oct 2026.

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