DANHEART (H-HeFT and Met-HeFT)

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

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)

Sponsors & Collaborators

• Danish Heart Foundation

  collaborator OTHER

• Danish Council for Independent Research

  collaborator OTHER

• The Danish Regions: Foundation for Medical Research

  collaborator UNKNOWN

• The Novo Nordisk Foundation

  collaborator UNKNOWN

• The Aase og Ejnar Danielsen Foundation

  collaborator UNKNOWN

• Henrik Wiggers

  lead OTHER

Principal Investigators

• Henrik Wiggers, MD, PhD · Dept. of Cardiology, Aarhus University Hospital, Aarhus, Denmark

• Lars Køber, MD, PhD · Dept. of Cardiology, Rigshospitalet, Copenhagen, Denmark

• Finn Gustafsson, MD, PhD · Dept. of Cardiology, Rigshospitalet, Copenhagen, Denmark

• Søren Mellemkjaer, MD, PhD · Dept. of Cardiology, Aarhus University Hospital, Aarhus, Denmark

• Gunnar Gislason, MD, PhD · The Danish Heart Foundation, Copenhagen, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-01

Primary Completion

2025-12-31

Completion

2025-12-31

FDA Drug

Yes

Countries

• Denmark

Study Locations