Care-HF CArdiac Resynchronization in Heart Failure

June 30, 2025 updated by: Medtronic Cardiac Rhythm and Heart Failure

Outcome Trial (Long Term)to Evaluate the Effects of Cardiac Resynchronization Therapy on the Mortality and Morbidity of Patients With Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

813 patients enrolled 82 centers in 12 countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK)

Study Type

Interventional

Enrollment

813

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
All cause mortality or unplanned cardiovascular hospitalization.

Secondary Outcome Measures

Outcome Measure
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
QOL at 90 days
End of study status
MECHANISTIC OUTCOME:Echocardiographic parameters, Neurohormonal parameters, Therapy delivery assessment
HEALTH ECONOMIC OUTCOME:Cost effectiveness of cardiac resynchronization will be assessed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic

Investigators

  • Study Chair: John Cleland, Professor, The University of Hull; Department of Cardiology; United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion

May 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimated)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Care-HF 2.02.02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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