Rationale and design of a randomized trial to assess the effects of diuretics in heart failure: Japanese Multicenter Evaluation of Long- vs Short-Acting Diuretics in Congestive Heart Failure (J-MELODIC).

BACKGROUND

Diuretics are the most prescribed medication for heart failure (HF) patients, but clinical evidence of the long-term effects of diuretics are lacking. The present study was designed to compare the therapeutic effects of furosemide, a short-acting loop diuretic, and azosemide, a long-acting one, in patients with HF to test the hypothesis that long-acting diuretics are superior therapy.

METHODS AND RESULTS

The Japanese Multicenter Evaluation of LOng- vs short-acting Diuretics In Congestive heart failure (J-MELODIC) is a multicenter, prospective, randomized trial enrolling a total of 300 patients (150 patients in each group). The primary outcome is a composite of cardiovascular death and unplanned admission to hospital for congestive HF. Other outcomes include all-cause mortality, worsening of the symptoms of HF, or a need for modification of therapy. Serial assessment of echocardiographic and neurohumoral parameters will be conducted over a minimum follow-up period of 2 years.

CONCLUSIONS

The study results will provide important evidence for the treatment of chronic HF.