NCT03514108

DANHEART (H-HeFT and Met-HeFT)

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,100 (actual)
• Sponsor: Henrik Wiggers · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Diabetes

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-03-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2018-05-02
• Last updated: 2026-04-07

Locations

26 sites across 1 country: Denmark

Regulatory

• FDA-regulated drug study