DANHEART (H-HeFT and Met-HeFT)

Last updated on July 2021

Recruitment

Recruitment Status: Recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Diabetes
Heart Failure

Type

Interventional

Phase

Phase 4

Design

Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: Patients can be allocated to either both Hydralazine Isosorbide Dinitrate / Placebo and Metformin hydrochloride / Placebo to only Hydralazine Isosorbide Dinitrate / Placebo. to only Metformin hydrochloride / Placebo. Patient characteristics are entered in an electronic CRF. According to in- and exclusion criteria they are randomized in three blocks: Patients receiving both Hydralazine Isosorbide Dinitrate / Placebo and Metformin hydrochloride / Placebo Patients receiving only Hydralazine Isosorbide Dinitrate / Placebo and Patients receiving only Metformin hydrochloride / Placebo Analysis will be performed in: all patients who have received Hydralazine Isosorbide Dinitrate / Placebo (H-HeFT) and all patients who have received Metformin hydrochloride / Placebo (Met-HeFT) The study is event driven. Anticipated: both H-HeFT and Met-HeFT 900, only H-HeFT 400, only Met-HeFT 200 patients.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 125 years
Gender: Both males and females

Description

Not Provided

Tracking Information

NCT #

NCT03514108

Collaborators

Danish Heart Foundation
Danish Council for Independent Research
The Danish Regions: Foundation for Medical Research
The Novo Nordisk Foundation
The Aase og Ejnar Danielsen Foundation

Investigators

Study Chair: Henrik Wiggers, MD, PhD Dept. of Cardiology, Aarhus University Hospital, Aarhus, Denmark Study Chair: Lars Køber, MD, PhD Dept. of Cardiology, Rigshospitalet, Copenhagen, Denmark Principal Investigator: Finn Gustafsson, MD, PhD Dept. of Cardiology, Rigshospitalet, Copenhagen, Denmark Principal Investigator: Søren Mellemkjaer, MD, PhD Dept. of Cardiology, Aarhus University Hospital, Aarhus, Denmark Study Chair: Gunnar Gislason, MD, PhD The Danish Heart Foundation, Copenhagen, Denmark