Trial Outcomes & Findings for CARE-HF Long Term Follow-up (NCT NCT00318357)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

309 participants

Primary outcome timeframe

8-year

Results posted on

2025-07-02

Participant Flow

Patient alive from original CARE-HF study consented for long term follow-up

Participant milestones

Participant milestones
Measure	Cardiac Resynchromization Therapy In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment. Medtronic CRT InSync® family devices : Implantation of CRT device and medical treatment according normal hospital routine.	Cardiac Resynchromization Therapy (Control Pts 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. After release Medtronic CRT InSync® family devices : Implantation of CRT device and medical treatment according normal hospital routine.
Overall Study STARTED	173	136
Overall Study COMPLETED	134	104
Overall Study NOT COMPLETED	39	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CARE-HF Long Term Follow-up

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cardiac Resynchromization Therapy (Control Pts in CARE-HF) n=136 Participants 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. With a recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine.	Cardiac Resynchromization Therapy n=173 Participants In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment. Medtronic CRT InSync® family devices : Implantation of CRT device and medical treatment according normal hospital routine.	Total n=309 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	65 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	45 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	97 Participants n=5 Participants	128 Participants n=7 Participants	225 Participants n=5 Participants
NYHA functional class III	132 participants n=5 Participants	165 participants n=7 Participants	297 participants n=5 Participants
QRS	160 ms n=5 Participants	160 ms n=7 Participants	160 ms n=5 Participants

PRIMARY outcome

Timeframe: 8-year

Population: Data from the CARE-HF and CARE-HF Long-Term Follow-Up studies were combined for analysis

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.

Outcome measures

Outcome measures
Measure	Cardiac Resynchronization Therapy n=173 Participants In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment. Medtronic CRT InSync® family devices : Implantation of CRT device and medical treatment according normal hospital routine.	Upgrade to Cardiac Resynchronization Therapy n=136 Participants 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. With a recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine.
All Cause Mortality	54.8 percentage of participants	64.8 percentage of participants

Adverse Events

Cardiac REsynchronization Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 39 deaths

Upgrade to Cardiac Resynchronization Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 32 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Cleland, Professor

The University of Hull; Department of Cardiology; United Kingdom

Phone: Telephone: 0044 1482 624084

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60