CARE-HF Long Term Follow-up

NCT00318357 | Completed Results DMC

• 1 other identifier: CARE-HF Long-term follow-up
• Study Type: observational
• Target: 309
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Cardiac Resynchronization therapy (CRT); All-cause mortality; Long-term follow-up

Outcome Measures

Primary Outcomes (1)

• All Cause Mortality

  Long-term mortality with cardiac resynchronization therapy in the Cardiac Resynchronization-Heart Failure (CARE-HF) trial. The patients that were still alive after closure of the CARE-HF study (2005,NCT00170300), that were willing to participate in the CARE-HF LTFU study continued additional follow-up for 4 years, till end 2009. The reported mortality data is the combined mortality of the CARE-HF and the CARE-HF LTFU study. Study start CARE-HF 2000.

  8-year

Study Arms (2)

CRT in CARE-HF

In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment. In the CARE-HF Long Term Follow-up part, all patients received CRT therapy on top of Optimal Medical Treatment. The CARE-HF LTFU study aims to further investigate mortality. CARE-HF LTFU study continued ot follow up the original CARE-HF CRT group patients.

Device: Continuation of CRT

Control in CARE-HF

In the CARE-HF study patients treated with standard medical treatment. In the CARE-HF Long Term Follow-up part, almost all patients received CRT therapy on top of Optimal Medical Treatment. The CARE-HF LTFU study aims to further investigate mortality. CARE-HF LTFU study continued to follow up the original CARE-HF control group patients.

Device: Upgrade to CRT

Interventions

Continuation of CRT DEVICE

Implantation of CRT device and medical treatment according normal hospital routine.

Also known as: Resynchronisation system of the InSync® family

CRT in CARE-HF

Upgrade to CRT DEVICE

Recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine.

Also known as: Resynchronisation system of the InSync® family

Control in CARE-HF

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Patients who have not participated in the CARE-HF program

Sponsors & Collaborators

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

Study Sites (1)

Hull Royal Infirmary - Academic Cardiology Unit

Cottingham, Kingston-Upon-Hull, HU16 5JQ, United Kingdom

Location

Related Publications (3)

• Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Klein W, Tavazzi L; CARE-HF study Steering Committee and Investigators. The CARE-HF study (CArdiac REsynchronisation in Heart Failure study): rationale, design and end-points. Eur J Heart Fail. 2001 Aug;3(4):481-9. doi: 10.1016/s1388-9842(01)00176-3.

  PMID: 11511435 BACKGROUND

• Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.

  PMID: 15753115 RESULT

• Cleland JG, Freemantle N, Erdmann E, Gras D, Kappenberger L, Tavazzi L, Daubert JC. Long-term mortality with cardiac resynchronization therapy in the Cardiac Resynchronization-Heart Failure (CARE-HF) trial. Eur J Heart Fail. 2012 Jun;14(6):628-34. doi: 10.1093/eurjhf/hfs055. Epub 2012 May 2.

  PMID: 22552183 RESULT

Biospecimen

Retention: NONE RETAINED

No biospecimens are retained

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: John Cleland, Professor
• Organization: The University of Hull; Department of Cardiology; United Kingdom

Telephone: 0044 1482 624084

Study Officials

• John Cleland, Professor

  The University of Hull; Department of Cardiology; United Kingdom

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2006
• First Posted: April 26, 2006
• Study Start: September 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 2, 2025
• Results First Posted: June 26, 2019

Record last verified: 2019-04

Locations

GB (1)