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DANHEART (H-HeFT and Met-HeFT)
Sponsor: Henrik Wiggers
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 in chronic heart failure patients with reduced LVEF. 2. The second hypothesis is that treatment with metformin in chronic heart failure patients with reduced LVEF and type 2 diabetes / diabetes risk / insulin resistance 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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1100
Start Date
2018-03-01
Completion Date
2025-12-31
Last Updated
2026-06-11
Healthy Volunteers
No
Conditions
Interventions
Hydralazine Isosorbide Dinitrate
Tablet BiDil (Hydralazine 37.5 mg/ Isosorbide Dinitrate (ISDN) 20 mg) 2 tablets x 3 daily
Placebo Oral Tablet
2 tablets x 3 daily
Metformin Hydrochloride
Tablet Metformin hydrochloride 500 mg 2 tablets x 2 daily (eGFR 35-60 ml/min: 500 mg x 2 daily)
Placebo Oral Tablet
2 tablets x 2 daily (eGFR 35-60 ml/min: 500 mg x 2 daily)
Locations (26)
Holbæk Hospital
Holbæk, Region Sjælland, Denmark
Sygehus Sønderjylland, Aabenraa
Aabenraa, Denmark
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Amager Hospital
Copenhagen, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Gentofte Hospital
Copenhagen, Denmark
Glostrup Hospital
Copenhagen, Denmark
Herlev Hospital
Copenhagen, Denmark
Hvidovre Hospital
Copenhagen, Denmark
Rigshospitalet
Copenhagen, Denmark
Sydvestjysk Sygehus, Esbjerg
Esbjerg, Denmark
Herning Hospital
Herning, Denmark
Nordsjællands Hospital Hillerød
Hillerød, Denmark
Regionshospital Nordjylland, Hjørring
Hjørring, Denmark
Holbæk Hospital
Holbæk, Denmark
Horsens Hospital
Horsens, Denmark
Kolding Hospital
Kolding, Denmark
Nykøbing Falster Hospital
Nykøbing Falster, Denmark
Odense University Hospital
Odense, Denmark
Randers Hospital
Randers, Denmark
Sjællands Universitetshospital, Roskilde
Roskilde, Denmark
Silkeborg Hospital
Silkeborg, Denmark
Slagelse Sygehus
Slagelse, Denmark
Vejle Hospital
Vejle, Denmark
Viborg Hospital
Viborg, Denmark