A Randomized, Double-blind, Placebo Controlled Study (DANHEART): Hydralazine-ISDN in Patients With Chronic Heart Failure - Hydralazine Heart Failure Trial (H-HeFT) and Metformin in Patients With Chronic Heart Failure and Diabetes or Insulin Resistance - Metformin Heart Failure Trial (Met-HeFT) (DANHEART)

  • End date
    Dec 31, 2026
  • participants needed
  • sponsor
    Henrik Wiggers
Updated on 23 October 2022
body mass index
heart failure
systolic blood pressure
type 2 diabetes mellitus
oral glucose tolerance test
insulin resistance
beta blockers
chronic heart failure
b-type natriuretic peptide
hemoglobin a1c
glycosylated hemoglobin
beta-adrenergic blocking agents
aldosterone antagonists
angiotensin ii receptor antagonists


The present study is testing in a combined design to types of drugs in patients with chronic heart failure: 1) Hydralazine in combination with isosorbide dinitrate (BiDil) and 2) Metformin hydrochloride. The study is double blind, placebo controlled.

  1. The first hypothesis is that hydralazine in combination with isosorbide dinitrate can reduce mortality and hospitalization with worsening heart failure.
  2. The second hypothesis is that treatment of underlying insulin resistance/ type 2 diabetes with metformin in heart failure patients with moderately to severely reduced LVEF can reduce mortality and cardiovascular hospitalizations. Among secondary endpoints are reduction in new-onset diabetes in heart failure patients with insulin resistance and diabetes risk profile and patient safety.

Condition Heart Failure, Diabetes
Treatment Metformin Hydrochloride, Placebo Oral Tablet, Hydralazine Isosorbide Dinitrate
Clinical Study IdentifierNCT03514108
SponsorHenrik Wiggers
Last Modified on23 October 2022


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