H-HeFT
Hydralazine-ISDN in Patients With Chronic Heart Failure — Hydralazine Heart Failure Trial (H-HeFT), component of the DANish randomised, double-blind, placebo-controlled trial in patients with chronic HEART failure (DANHEART)
Patient / Population Intervention / Exposition Comparaison Critère de jugement
In 1,300 patients with HFrEF on guideline-directed therapy, hydralazine–isosorbide dinitrate was compared with placebo on death or worsening heart failure.
N
1 300
Schéma
investigator-initiated, multicentre (20 Danish public hospitals), randomised 1:1, double-blind, placebo-controlled, event-driven; 2 × 2 factorial with Met-HeFT (patients may enter one or both substudies); fixed-dose hydralazine 37.5 mg/isosorbide dinitrate 20 mg uptitrated from one tablet twice daily to two tablets three times daily vs matching placebo; anticipated mean follow-up 4 years
Critère
Time to first occurrence of the composite of death or hospitalisation with worsening heart failure (including an urgent visit requiring intravenous therapy or metolazone for heart failure, heart transplantation or LVAD implantation)