| Trial ID: | L4653 |
| Source ID: | NCT03514108
|
| Associated Drug: |
Hydralazine Isosorbide Dinitrate
|
| Title: |
DANHEART (H-HeFT and Met-HeFT)
|
| Acronym: |
DANHEART
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Heart Failure|Diabetes
|
| Interventions: |
DRUG: Hydralazine Isosorbide Dinitrate|DRUG: Placebo Oral Tablet|DRUG: Metformin Hydrochloride|DRUG: Placebo Oral Tablet
|
| Outcome Measures: |
Primary: H-HeFT combined endpoint: Death or hospitalization with worsening heart failure or urgent heart failure visit, Death or hospitalization with worsening heart failure or urgent heart failure visit resulting in intravenous therapy or metolazone treatment for heart failure., Through study completion, an average of 4 years|Met-HeFT combined endpoint: Death or hospitalization with worsening heart failure or acute myocardial infarction or stroke or urgent heart failure visit, Death or hospitalization with worsening heart failure or acute myocardial infarction or stroke or urgent visit resulting in intravenous therapy or metolazone treatment for heart failure, Through study completion, an average of 4 years | Secondary: H-HeFT secondary endpoint: Death, Death, Through study completion, an average of 4 years|H-HeFT secondary endpoint: Hospitalization with worsening heart failure or urgent visit resulting in intravenous therapy or metolazone therapy for heart failure, Hospitalization with worsening heart failure or urgent visit resulting in intravenous therapy or metolazone therapy for heart failure, Through study completion, an average of 4 years|H-HeFT secondary endpoint: Combined endpoint: Death or cardiovascular hospitalization or urgent heart failure visit, Combined endpoint: Death or cardiovascular hospitalizations (hospitalization with worsening heart failure, acute myocardial infarction, or stroke) or urgent visit resulting in intravenous therapy or metolazone therapy for heart failure, Through study completion, an average of 4 years|Met-HeFT secondary endpoint: Extended clinical endpoint: The primary endpoint or coronary revascularization or non-coronary revascularization or limb amputation., Extended clinical endpoint: The primary endpoint or coronary revascularization or non-coronary revascularization or limb amputation., Through study completion, an average of 4 years|Met-HeFT secondary endpoint: Death, Death, Through study completion, an average of 4 years|Met-HeFT secondary endpoint: Hospitalization with worsening heart failure or urgent visit resulting in intravenous therapy or metolazone therapy for heart failure, Hospitalization with worsening heart failure or urgent visit resulting in intravenous therapy or metolazone therapy for heart failure, Through study completion, an average of 4 years|Met-HeFT secondary endpoint: Acute myocardial infarction, Acute myocardial infarction, Through study completion, an average of 4 years|Met-HeFT secondary endpoint: Stroke, Stroke, Through study completion, an average of 4 years|Met-HeFT secondary endpoint: New onset type 2 diabetes, New onset type 2 diabetes, Through study completion, an average of 4 years|Met-HeFT secondary endpoint: Hospitalization or death caused by lactate acidosis., Hospitalization or death caused by lactate acidosis., Through study completion, an average of 4 years
|
| Sponsor/Collaborators: |
Sponsor: Henrik Wiggers | 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
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
1500
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-03-01
|
| Completion Date: |
2026-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2023-05-31
|
| Locations: |
Sygehus Sønderjylland, Aabenraa, Aabenraa, Denmark|Aalborg University Hospital, Aalborg, Denmark|Aarhus University Hospital, Aarhus, Denmark|Amager Hospital, Copenhagen, Denmark|Bispebjerg Hospital, Copenhagen, Denmark|Gentofte Hospital, Copenhagen, Denmark|Glostrup Hospital, Copenhagen, Denmark|Herlev Hospital, Copenhagen, Denmark|Hvidovre Hospital, Copenhagen, Denmark|Rigshospitalet, Copenhagen, Denmark|Sydvestjysk Sygehus, Esbjerg, Esbjerg, Denmark|Herning Hospital, Herning, Denmark|Nordsjællands Hospital Hillerød, Hillerød, Denmark|Regionshospital Nordjylland, Hjørring, Hjørring, Denmark|Holbæk Hospital, Holbæk, Denmark|Horsens Hospital, Horsens, Denmark|Kolding Hospital, Kolding, Denmark|Nykøbing Falster Hospital, Nykøbing Falster, Denmark|Odense University Hospital, Odense, Denmark|Randers Hospital, Randers, Denmark|Sjællands Universitetshospital, Roskilde, Roskilde, Denmark|Silkeborg Hospital, Silkeborg, Denmark|Slagelse Sygehus, Slagelse, Denmark|Vejle Hospital, Vejle, Denmark|Viborg Hospital, Viborg, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT03514108
|
