In sufferers with coronary heart failure, hydralazine with isosorbide dinitrate didn’t considerably enhance the incidence of dying or coronary heart failure occasions and remedy discontinuation charges had been excessive. These had been the principle findings of the H-HeFT trial introduced in a Sizzling Line session as we speak at ESC Congress 2026.
Coronary heart failure stays a standard and lethal illness. Principal Investigator, Professor Lars Køber from Rigshospitalet – Copenhagen College Hospital, Copenhagen, Denmark, defined that the H-HeFT trial was carried out to evaluate whether or not an current drug may deliver advantages to a wider inhabitants. “Over 20 years in the past, the A-HeFT research demonstrated a 43% discount in mortality with the mix of hydralazine with isosorbide dinitrate (H-ISDN) when given on high of established coronary heart failure remedy at the moment,” he famous. “The research inhabitants consisted of Black sufferers with coronary heart failure and lowered ejection fraction and the H-ISDN mixture has by no means been examined extra broadly. The H-HeFT trial was designed to additional consider H-ISDN in sufferers with coronary heart failure.”
The investigator-initiated, double-blind H-HeFT trial was carried out in 23 facilities in Denmark as a part of DANHEART. DANHEART had a factorial design, evaluating H-ISDN in sufferers with power coronary heart failure (H-HeFT trial) and metformin in sufferers with power coronary heart failure and diabetes or prediabetes (Met-HeFT trial; additionally introduced at ESC Congress 2026).
Within the H-HeFT trial, eligible sufferers had symptomatic power coronary heart failure, a left ventricular ejection fraction of as much as 40% and had been required to have systolic blood strain of no less than 100 mmHg and elevated ranges of a coronary heart pressure marker (NT-proBNP >350 pg/mL or BNP >80 pg/mL). A complete of 592 contributors had been randomized (1:1) to twice-daily hydralazine 37.5 mg plus isosorbide dinitrate 20 mg (with uptitration) or matching placebo. The imply age was round 70 years and roughly 17% had been girls. The first endpoint was a composite of dying, worsening coronary heart failure, an pressing outpatient go to leading to intravenous remedy or metolazone remedy for coronary heart failure, coronary heart transplantation or left ventricular help gadget implantation.
Over follow-up of as much as seven years, there was no vital distinction between H-ISDN and placebo for the first endpoint (8.6 occasions/100 patient-years vs. 9.3 occasions/100 patient-years; hazard ratio [HR] 0.90; 95% confidence interval [CI] 0.67 to 1.21). All-cause dying occurred in 19.4% of sufferers within the H-ISDN group and 24.2% of sufferers within the placebo group (HR 0.72; 95% CI 0.51 to 1.02).
Professor Køber commented that the outcomes of the trial could have been impacted by the excessive variety of sufferers who discontinued H-ISDN remedy, though there didn’t look like any security issues.
Whether or not there may very well be a discount in mortality with H-ISDN requires a brand new randomized managed trial.”
Professor Lars Køber, Rigshospitalet – Copenhagen College Hospital, Copenhagen, Denmark
Additionally on the congress, Physician Jawad Haider Butt, from the identical establishment, introduced a meta-analysis of three trials evaluating H-ISDN remedy, together with A-HeFT and H-HeFT. Knowledge from 2,101 sufferers with coronary heart failure had been analyzed. H-ISDN was related to a discount in all-cause dying (HR 0.71; 95% CI 0.58 to 0.87) and cardiovascular dying (HR 0.65; 95% CI 0.47 to 0.90), however outcomes on hospitalisations for coronary heart failure had been inconsistent. Substantial variations in trial design, period of follow-up and background therapies had been famous throughout the trials.
“Given the heterogeneity and the tolerability points, it’s tough to make agency conclusions on the impact of H-ISDN on cardiovascular outcomes,” concluded Physician Butt.
Supply:
