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COMPLETED
NCT03514108
PHASE4

DANHEART (H-HeFT and Met-HeFT)

Sponsor: Henrik Wiggers

View on ClinicalTrials.gov

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

Interventions

DRUG

Hydralazine Isosorbide Dinitrate

Tablet BiDil (Hydralazine 37.5 mg/ Isosorbide Dinitrate (ISDN) 20 mg) 2 tablets x 3 daily

DRUG

Placebo Oral Tablet

2 tablets x 3 daily

DRUG

Metformin Hydrochloride

Tablet Metformin hydrochloride 500 mg 2 tablets x 2 daily (eGFR 35-60 ml/min: 500 mg x 2 daily)

DRUG

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