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Cardiac Contractility Modulation Improves Exercise Tolerance and QOL in Patients With Advanced Heart Failure and Left Ventricular Dysfunction: Presented at HF2008 By Chris Berrie MILAN, Italy -- June 19, 2008 -- Nonexcitatory cardiac contractility modulation (CCM) with electrical impulses is safe and can significantly improve exercise tolerance and quality of life for patients with advanced heart failure (HF) and left ventricular (LV) dysfunction, according to a multicentre, randomised, double-blind, crossover study. Coauthor Milena Schirru, MD, Hospital AO Niguarda, Milan, Italy, presented the study findings here on June 16 at the Heart Failure 2008 (HF2008) Congress. CCM involves the application of electrical signals during the absolute refractory period, Dr. Schirru explained, and has been shown to enhance ventricular contractile strength independent of myocardial contraction synchrony. In the study, Dr. Schirru's research team enrolled patients with medically-refractory, chronic HF not eligible for cardiac resynchronisation therapy, with left ventricular ejection fraction (LVEF) up to 35% and peak oxygen uptake (VO2) of 10 to 20 mL/min/kg. Coprimary endpoints were peak differences in VO2 and quality of life between treatment groups as measured with the Minnesota Living With Heart Failure Questionnaire (MLWHFQ) as well as a 6-minute walking test (6MWT). The study population included 164 patients with ischaemic (60%) and idiopathic (40%) cardiomyopathy and New York Heart Association classes II/III (24%/76%) who were on optimal standard therapy. For the crossover design, 2 weeks after the successful implantation of the CCM device, 80 patients were randomly assigned to group 1 for 3 months of CCM treatment plus 3 months of sham treatment and 84 patients were assigned to group 2 for sham treatment followed by CCM. The characteristics of the 2 groups were similar at baseline for LVEF (29.3%, 29.8%, respectively), peak VO2 (14.1, 13.6 mL/kg/min), and MLWHFQ (38.9, 36.5). This design thus minimised placebo effects following the crossover, as seen from the nonsignificance of the differences in coprimary endpoints between groups at 3 months, after the first treatment period. After the second treatment period, however, CCM treatment showed significantly improved changes over sham treatment for peak VO2 (0.16 vs -0.86 mL/kg/min; P = .0032) and quality of life (-0.70 vs 4.70; P = .03) and a significantly improved 6MWT (P = .05). Dr. Schirru said, "In these patients with refractory chronic heart failure who are already on optimal treatment, [nonexcitatory cardiac contractility modulation] is a real help, as we see that it significantly improves their functional abilities." [Presentation title: Randomised, Double-Blind Study of Non-Excitatory, Cardiac Contractility Modulation (CCM) Electrical Impulses for Advanced Heart Failure. Abstract P676] E-mail this page to a friend or colleague! To print, use this version