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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)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
March 1, 2018
Primary Completion Date
December 31, 2025
Completion Date
December 31, 2025
Last Updated
February 20, 2026
1,100
ACTUAL participants
Hydralazine Isosorbide Dinitrate
DRUG
Placebo Oral Tablet
DRUG
Metformin Hydrochloride
DRUG
Placebo Oral Tablet
DRUG
Lead Sponsor
Henrik Wiggers
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07484009