CARE-HF LTFU: CArdiac REsynchronization in Heart Failure Long-Term Follow-up

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Medtronic Bakken Research Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00318357
First received: April 25, 2006
Last updated: May 30, 2008
Last verified: May 2008
  Purpose

The CARE-HF long-term follow-up trial evaluates the effects of cardiac resynchronization (CR) therapy on the mortality of patients from the CARE-HF program for an additional 4 year follow-up. Investigators are free to choose whatever available treatment they believe is in the patient's best interest.


Condition Intervention Phase
Heart Failure
Device: Medtronic CRT InSync® family devices
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CARE-HF LTFU: CArdiac REsynchronization in Heart Failure Long-Term Follow-up

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • All cause Mortality [ Time Frame: 4-year ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

No biospecimens are retained


Estimated Enrollment: 550
Study Start Date: September 2006
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CRT
In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment.
Device: Medtronic CRT InSync® family devices
Implantation of CRT device and medical treatment according normal hospital routine.
Other Name: Resynchronisation system of the InSync® family

Detailed Description:

The CARE-HF study enrolled 813 patients from 82 centers in 12 European countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK). All patients that were reported to be alive in May 2005 will be asked to participate.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chronic heart failure patients with NYHA class III-IV,with a LVEF of less than or equal to 35%, who are on optimal medical treatment, and documented evidence of ventricular dyssynchrony as evidenced by QRS or Echo prior enrollment in the CARE-HF main study.

Patients who have participated in the CARE-HF program and were reported to be alive in May 2005 (study closure of the main study) are asked to participate in the CARE-HF LTFU study.

Criteria

Inclusion Criteria:

  • Patients who have participated in the CARE-HF program and were reported to be alive in May 2005
  • Patients who signed a patient data release consent form

Exclusion Criteria:

  • Patients who have not participated in the CARE-HF program
  • Patients with exclusion criteria required by local legislation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318357

Locations
United Kingdom
Hull Royal Infirmary - Academic Cardiology Unit
Cottingham, Kingston-Upon-Hull, United Kingdom, HU16 5JQ
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
Study Chair: John Cleland, Professor The University of Hull; Department of Cardiology; United Kingdom
  More Information

No publications provided

Responsible Party: Monique Marijianowski, PhD, Medtronic
ClinicalTrials.gov Identifier: NCT00318357     History of Changes
Other Study ID Numbers: CARE-HF Long-term follow-up
Study First Received: April 25, 2006
Last Updated: May 30, 2008
Health Authority: European Union: European Medicines Agency

Keywords provided by Medtronic Bakken Research Center:
Cardiac Resynchronization therapy (CRT)
All-cause mortality
Long-term follow-up

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014