Heart FailureNCT00170300
Care-HF CArdiac Resynchronization in Heart Failure
A study testing Implantable Cardiac Resynchronisation (pacing) device in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Implantable Cardiac Resynchronisation (pacing) device
- Type of treatment
- Medical device
- How many people
- 813 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to May 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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;
Show all 13Show fewer
- 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;
About this study
Official title: 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.
Read the detailed description
813 patients enrolled 82 centers in 12 countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK)
- Conditions
- Heart Failure
- Being tested
- Implantable Cardiac Resynchronisation (pacing) device
- 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
- Medical subject headings
- Heart Failure, Creatine deficiency, X-linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Cardiac Resynchronisation (pacing) deviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2001
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Factorial
- Masking
- None (open label)
- Enrolment
- 813 participants
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Investigators
- John Cleland, Professor, Study chair, The University of Hull; Department of Cardiology; United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170300
- Sponsor's protocol ID
- Care-HF 2.02.02
- Status last verified
- Jan 2018
- First submitted
- 9 Sep 2005
- Last updated
- 3 Jul 2025
- Results posted
- No
Publications
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.
PubMed 35490339Linde 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.
PubMed 29314424Cleland 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.
PubMed 23900696Damy 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.
PubMed 23541971Cleland 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.
PubMed 18672164
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Trial (Long Term)to Evaluate the Effects of Cardiac Resynchronization Therapy on the Mortality and Morbidity of Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT00170300
- Acronym / sponsor ID
- Care-HF 2.02.02
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 813 participants
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Jan 2001
- Study completion
- May 2005
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
813 patients enrolled 82 centers in 12 countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable Cardiac Resynchronisation (pacing) device | Device | – |
Primary outcome
All cause mortality or unplanned cardiovascular hospitalization.
9 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Derived from this study: PubMed 35490339Cleland 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.
- Derived from this study: PubMed 29314424Linde 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.
- Derived from this study: PubMed 23900696Cleland 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.
- Derived from this study: PubMed 23541971Damy 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.
- Derived from this study: PubMed 18672164Cleland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Cleland, Professor study chair
The University of Hull; Department of Cardiology; United Kingdom
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Cardiac Resynchronisation (pacing) device in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality or unplanned cardiovascular hospitalization.. 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 NCT00170300, which also lists 5 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 3 Jul 2025.