Bridging the Gap in Heart Failure Prevention: Rationale and Design of the Nurse-Led Intervention for Less Chronic Heart Failure (NIL-CHF) Study

AIMS: 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). Methods 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, approximately 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%. CONCLUSION: 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.