DANHEART (H-HeFT and Met-HeFT)

Sponsor
Henrik Wiggers
Study ID
NCT03514108
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hydralazine Isosorbide Dinitrate — DRUG
    Tablet BiDil (Hydralazine 37.5 mg/ Isosorbide Dinitrate (ISDN) 20 mg) 2 tablets x 3 daily
  • Placebo Oral Tablet — DRUG
    2 tablets x 3 daily
  • Metformin Hydrochloride — DRUG
    Tablet Metformin hydrochloride 500 mg 2 tablets x 2 daily (eGFR 35-60 ml/min: 500 mg x 2 daily)
  • Placebo Oral Tablet — DRUG
    2 tablets x 2 daily (eGFR 35-60 ml/min: 500 mg x 2 daily)

Study Details

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.

Key Dates

Start date
Mar 1, 2018
Status verified
Apr 2026
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
1,100 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Hydralazine Isosorbide Dinitrate
    Tablet BiDil (Hydralazine 37.5 mg/ isosorbide dinitrate (ISDN) 20 mg) 2 tablets x 3 daily. Average treatment period 4 years.
  • Placebo Comparator: Placebo (Hydralazine Isosorbide Dinitrate)
    Tablet Placebo 2 tablets x 3 daily. Average treatment period 4 years.
  • Active Comparator: Metformin
    Tablet Metformin hydrochloride 500 mg 2 tablets x 2 daily (eGFR 35-60 ml/min: 500 mg x 2 daily). Average treatment period 4 years.
  • Placebo Comparator: Placebo (Metformin)
    Tablet Placebo 500 mg 2 tablets x 2 daily (eGFR 35-60 ml/min: 500 mg x 2 daily). Average treatment period 4 years.

Primary Outcome Measure

H-HeFT combined primary endpoint [ Time Frame: Through study completion, an average of 4 years ]

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