Clinical Trials
FIX-HF-5C
Acronym: Evaluate Safety and Efficacy of the Optimizer System in Subjects with Moderate-to-Severe Heart Failure
Purpose: Researchers assessed the safety and efficacy of cardiac contractility modulation with a device (Optimizer, Impulse Dynamics) in patients with heart failure with ejection fraction between 25% and 45%
Format: Randomized, parallel-assignment, open-label
Treatment Group: Cardiac contractility modulation with the Optimizer device
Control Group: Continued medical therapy
Number of Participants: 160
Centers: 42
Inclusion Criteria:
- New York Heart Association functional class III or IV heart failure
- QRS duration < 130 ms
- Ejection fraction between 25% and 45%
Primary Outcome(s): Peak VO2
Secondary Outcome(s):
- Minnesota Living with Heart Failure questionnaire score
- New York Heart Association functional class
- 6-minute walk distance test
- Key safety outcome: Freedom from device-related adverse events, with a prespecified lower bound of 70%
Follow-up: 24 weeks
Summary: At 24 weeks, peak VO2 was 15.042 mL O2/kg/min in the cardiac contractility group and 14.206 mL O2/kg/min in the control group. The probability that cardiac contractility modulation is superior to control was 0.989, exceeding the criterion for statistical significance of 0.975. Also at 24 weeks, the treatment group had better Minnesota Living with Heart Failure questionnaire score and had better performance on the 6-minute walk distance test.
Original Publication:
Abraham WT, et al. JACC Heart Fail. 2018;doi:10.1016/j.jchf.2018.04.010.
Link to Cardiology Today Article: