Overview

DANHEART (H-HeFT and Met-HeFT)

Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Henrik Wiggers
Collaborators:
Danish Council for Independent Research
Danish Heart Foundation
The Aase og Ejnar Danielsen Foundation
The Danish Regions: Foundation for Medical Research
The Novo Nordisk Foundation
Treatments:
Hydralazine
Isosorbide
Isosorbide Dinitrate
Isosorbide-5-mononitrate
Metformin