Cardiac contractility modulation significantly improved peak VO2 by 0.84 ml O2/kg/min compared to optimal medical therapy at 24 weeks in patients with heart failure and ejection fraction between 25% and 45%.
RCT (n=160)
Open-label
1:1
Yes
Effect estimate: Difference 0.84 ml O2/kg/min (95% CI 0.123-1.552)
Absolute Event Rate: 15.04% vs 14.2%
p-value: p=0.989 (posterior probability)
OBJECTIVES: This study sought to confirm a subgroup analysis of the prior FIX-HF-5 (Evaluate Safety and Efficacy of the OPTIMIZER System in Subjects With Moderate-to-Severe Heart Failure) study showing that cardiac contractility modulation (CCM) improved exercise tolerance (ET) and quality of life in patients with ejection fractions between 25% and 45%. BACKGROUND: CCM therapy for New York Heart Association (NYHA) functional class III and IV heart failure (HF) patients consists of nonexcitatory electrical signals delivered to the heart during the absolute refractory period. METHODS: (primary endpoint), Minnesota Living With Heart Failure questionnaire, NYHA functional class, and 6-min hall walk were measured at baseline and at 12 and 24 weeks. Bayesian repeated measures linear modeling was used for the primary endpoint analysis with 30% borrowing from the FIX-HF-5 subgroup. Safety was assessed by the percentage of patients free of device-related adverse events with a pre-specified lower bound of 70%. RESULTS: /kg/min, satisfying the primary endpoint. Minnesota Living With Heart Failure questionnaire (p < 0.001), NYHA functional class (p < 0.001), and 6-min hall walk (p = 0.02) were all better in the treatment versus control group. There were 7 device-related events, yielding a lower bound of 80% of patients free of events, satisfying the primary safety endpoint. The composite of cardiovascular death and HF hospitalizations was reduced from 10.8% to 2.9% (p = 0.048). CONCLUSIONS: CCM is safe, improves exercise tolerance and quality of life in the specified group of HF patients, and leads to fewer HF hospitalizations. (Evaluate Safety and Efficacy of the OPTIMIZER System in Subjects With Moderate-to-Severe Heart Failure; NCT01381172).
Abraham et al. (Thu,) conducted a rct in Heart Failure (n=160). Cardiac contractility modulation (CCM) vs. Optimal medical therapy alone was evaluated on Difference in peak VO2 at 24 weeks (Difference 0.84 ml O2/kg/min, 95% CI 0.123-1.552, p=0.989 (posterior probability)). Cardiac contractility modulation significantly improved peak VO2 by 0.84 ml O2/kg/min compared to optimal medical therapy at 24 weeks in patients with heart failure and ejection fraction between 25% and 45%.