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Hydralazine-ISDN in Patients With Chronic Heart Failure - Hydralazine Heart Failure Trial (H-HeFT) Metformin in Patients with Chronic Heart Failure and Diabetes or Insulin Resistance - Metformin Heart Failure Trial (Met-HeFT) A randomized, 2 x 2 factorial designed, double-blind, placebo controlled study (DANHEART).

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514212-27-00
Acronym
DANHEART
Enrollment
1500
Registered
2024-09-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Brief summary

H-HeFT: Death or hospitalization with worsening heart failure or an urgent visit resulting in intravenous therapy or metolazone therapy for heart failure or heart transplantation or implantation of a left ventricular assist device (LVAD)., Met-HeFT: A composite of total (first and recurrent) events in the primary endpoint: Death or hospitalization with worsening heart failure or an urgent visit resulting in intravenous therapy or metolazone therapy for heart failure or heart transplantation or implantation of a LVAD or acute myocardial infarction or stroke

Detailed description

H-HeFT: 1. Individual components of the primary endpoint, H-HeFT: 2. Combined endpoint: Death or cardiovascular hospitalizations (hospitalization with worsening heart failure or heart transplantation or implantation of a left ventricular assist device (LVAD) or acute myocardial infarction or stroke or acute myocardial infarction or stroke), Met-HeFT: 1. Extended clinical endpoint: The primary endpoint or coronary revascularization or non-coronary revascularization or limb amputation., Met-HeFT: 2. New diagnosis of diabetes mellitus, Met-HeFT: 3. Hospitalization/ death due to lactate acidosis, Met-HeFT: 4. Individual components of the primary endpoint, H-HeFT: Change in NT-proBNP from baseline to final follow-up, Met-HeFT: Change in NT-proBNP from baseline to final follow-up, Met-HeFT: Combined endpoint, first event: Death or hospitalization with worsening heart failure or an urgent visit resulting in intravenous therapy or metolazone therapy for heart failure or heart transplantation or implantation of a LVAD or acute myocardial infarction or stroke, Met-HeFT: Total hospitalizations

Interventions

DRUGBiDil
DRUGPlacebo (to Hydralazine / Isosorbide dinitrate)
DRUGPlacebo (To Metformin hydrochloride)
DRUGMETFORMIN HYDROCHLORIDE

Sponsors

Aarhus Universitetshospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
H-HeFT: Death or hospitalization with worsening heart failure or an urgent visit resulting in intravenous therapy or metolazone therapy for heart failure or heart transplantation or implantation of a left ventricular assist device (LVAD)., Met-HeFT: A composite of total (first and recurrent) events in the primary endpoint: Death or hospitalization with worsening heart failure or an urgent visit resulting in intravenous therapy or metolazone therapy for heart failure or heart transplantation or implantation of a LVAD or acute myocardial infarction or stroke

Secondary

MeasureTime frame
H-HeFT: 1. Individual components of the primary endpoint, H-HeFT: 2. Combined endpoint: Death or cardiovascular hospitalizations (hospitalization with worsening heart failure or heart transplantation or implantation of a left ventricular assist device (LVAD) or acute myocardial infarction or stroke or acute myocardial infarction or stroke), Met-HeFT: 1. Extended clinical endpoint: The primary endpoint or coronary revascularization or non-coronary revascularization or limb amputation., Met-HeFT: 2. New diagnosis of diabetes mellitus, Met-HeFT: 3. Hospitalization/ death due to lactate acidosis, Met-HeFT: 4. Individual components of the primary endpoint, H-HeFT: Change in NT-proBNP from baseline to final follow-up, Met-HeFT: Change in NT-proBNP from baseline to final follow-up, Met-HeFT: Combined endpoint, first event: Death or hospitalization with worsening heart failure or an urgent visit resulting in intravenous therapy or metolazone therapy for heart failure or heart transplantation o

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026