The primary objective of the Nurse-led Intervention for Less Chronic Heart Failure (NIL-CHF) Study is to develop a programme of care that cost-effectively prevents the development of chronic heart failure (CHF).
NIL-CHF is a randomized controlled trial of a hybrid, home- and clinic-based, nurse-led multidisciplinary intervention targeting hospitalized patients at risk of developing CHF. A target of 750 patients aged ≥45 years will be exposed to usual post-discharge care or the NIL-CHF intervention. The composite primary endpoint is all-cause mortality or CHF-related admission during 3–5 years of follow-up. After 12 months recruitment, ~300 eligible patients (40% of target) have been randomized. Overall, 73% are male and the mean age is 65 ± 10 years. The most common antecedents for CHF thus far are hypertension (70%, 95% CI, 64–75%), coronary artery disease (51%, 95% CI, 31–41%), and type 2 diabetes (26%, 95% CI, 21–31%), whereas 76% (95% CI, 69–82%) of patients have diastolic dysfunction, 29% (95% CI, 23–36%) left ventricular hypertrophy, 71% (95% CI, 64–78%) mitral valve dysfunction, and 7% (95% CI, 4–12%) have a left ventricular ejection fraction ≤45%.
As one of the largest randomized studies of its kind, NIL-CHF will ultimately provide important insights into the potential to prevent CHF via prolonged and intensive disease management.
Elevated heart rate is a significant marker for mortality and morbidity in cardiovascular disease including heart failure. Despite background treatment with a beta-blocker, many patients with heart failure and low ejection fraction maintain a heart rate above 70 b.p.m. Ivabradine reduces heart rate directly through inhibition of the If ionic current.
SHIFT is a randomized, double-blind study designed to compare ivabradine with placebo on outcomes in patients with symptomatic chronic heart failure (NYHA class II–IV), left-ventricular ejection fraction ≤35%, and a prior hospitalization for worsening heart failure within the previous 12 months. Randomized treatment is given on top of guidelines-based therapy for chronic heart failure, including a beta-blocker at optimized dose. Resting heart rate at baseline must be ≥70 b.p.m. The primary endpoint is the composite of the time to first event of cardiovascular death or hospitalization for worsening heart failure. Secondary endpoints include all-cause, cardiovascular and heart failure mortality, and hospitalization. The randomized treatment period lasts approximately 12–48 months. The study will include approximately 6500 patients and will continue until ≥1600 primary endpoints have occurred. The first patient was randomized in October 2006, and the study is expected to end in 2010.
The SHIFT study will assess if a heart rate reduction by direct sinus node inhibition can reduce cardiovascular outcomes in patients with chronic heart failure and left-ventricular systolic dysfunction.