Care-HF CArdiac Resynchronization in Heart Failure

NCT00170300 | Completed

• 1 other identifier: Care-HF 2.02.02
• Study Type: interventional
• Target: 813
• Locations: 0 countries
• Sites: N/A

Brief Summary

The CARE-HF trial evaluates the effects of Cardiac Resynchronization (CR) therapy on the mortality and morbidity of patients with heart failure due to left ventricular systolic dysfunction already receiving diuretics and optimal medical therapy.

Conditions

Heart Failure

Keywords

Cardiac resynchronisation therapy (CRT therapy),; all-cause mortality,; quality of life assesment,; echocardiographic left ventricular function,; CRT and neurohormonal activation,; CRT and health economics

Outcome Measures

Primary Outcomes (1)

• All cause mortality or unplanned cardiovascular hospitalization.

Secondary Outcomes (9)

• All cause mortality

• All cause mortality or unplanned hospitalization for or with worsening Heart Failure

• Days alive and not in hospital for unplanned cardiovascular cause

• Days alive and not in hospital for any reason

• NYHA class at 90 days

Interventions

Implantable Cardiac Resynchronisation (pacing) device DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heart failure for at least 6 weeks requiring loop diuretics
• Currently in NYHA class III/IV
• A high standard of pharmacological therapy
• LV systolic dysfunction and dilation (EF \<=35%; EDD \>30mm/height in metres)
• QRS \>=120 ms Dyssynchrony confirmed by echo if QRS 120-149 ms (Aortic pre-ejection delay \>140ms, Interventricular mechanical delay \>40 ms, Delayed activation of postero-lateral LV wall)

You may not qualify if:

• Age \< 18 years old or age \< legal age defined in the country in case different
• Chronic atrial fibrillation within 6 weeks prior to randomization;
• Impairment of left ventricular function not related to left ventricular systolic function
• Potentially reversible forms of cardiomyopathy:
• Cardiac surgery, percutaneous coronary intervention, cardiomyoplasty, myocardial infarction,unstable severe angina or stroke within 6 weeks before randomization
• A conventional indication for bradyarrhythmia pacing exists;
• A conventional indication for an ICD exists
• A pacemaker or ICD has already been implanted;
• In-Patients requiring continuous intravenous therapy for Heart Failure;
• Life expectancy \< 1 year for disease unrelated to Heart Failure;
• Pregnancy or childbearing potential and not on reliable contraceptive;
• Mechanical tricuspid valve;
• Anticipated compliance problem or participation in another trial;

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator

Related Publications (5)

• Cleland JGF, Bristow MR, Freemantle N, Olshansky B, Gras D, Saxon L, Tavazzi L, Boehmer J, Ghio S, Feldman AM, Daubert JC, de Mets D. The effect of cardiac resynchronization without a defibrillator on morbidity and mortality: an individual patient data meta-analysis of COMPANION and CARE-HF. Eur J Heart Fail. 2022 Jun;24(6):1080-1090. doi: 10.1002/ejhf.2524. Epub 2022 May 22.

  PMID: 35490339 DERIVED

• Linde C, Cleland JGF, Gold MR, Claude Daubert J, Tang ASL, Young JB, Sherfesee L, Abraham WT. The interaction of sex, height, and QRS duration on the effects of cardiac resynchronization therapy on morbidity and mortality: an individual-patient data meta-analysis. Eur J Heart Fail. 2018 Apr;20(4):780-791. doi: 10.1002/ejhf.1133. Epub 2018 Jan 4.

  PMID: 29314424 DERIVED

• Cleland JG, Abraham WT, Linde C, Gold MR, Young JB, Claude Daubert J, Sherfesee L, Wells GA, Tang AS. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure. Eur Heart J. 2013 Dec;34(46):3547-56. doi: 10.1093/eurheartj/eht290. Epub 2013 Jul 29.

  PMID: 23900696 DERIVED

• Damy T, Ghio S, Rigby AS, Hittinger L, Jacobs S, Leyva F, Delgado JF, Daubert JC, Gras D, Tavazzi L, Cleland JG. Interplay between right ventricular function and cardiac resynchronization therapy: an analysis of the CARE-HF trial (Cardiac Resynchronization-Heart Failure). J Am Coll Cardiol. 2013 May 28;61(21):2153-60. doi: 10.1016/j.jacc.2013.02.049. Epub 2013 Mar 26.

  PMID: 23541971 DERIVED

• Cleland J, Freemantle N, Ghio S, Fruhwald F, Shankar A, Marijanowski M, Verboven Y, Tavazzi L. Predicting the long-term effects of cardiac resynchronization therapy on mortality from baseline variables and the early response a report from the CARE-HF (Cardiac Resynchronization in Heart Failure) Trial. J Am Coll Cardiol. 2008 Aug 5;52(6):438-45. doi: 10.1016/j.jacc.2008.04.036.

  PMID: 18672164 DERIVED

MeSH Terms

Conditions

Heart Failure; Creatine deficiency, X-linked

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• John Cleland, Professor

  The University of Hull; Department of Cardiology; United Kingdom

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: January 1, 2001
• Study Completion: May 1, 2005
• Last Updated: July 3, 2025

Record last verified: 2018-01