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DANHEART (H-HeFT and Met-HeFT) (DANHEART)

Primary Purpose

Heart Failure, Diabetes

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Hydralazine Isosorbide Dinitrate
Placebo Oral Tablet
Metformin Hydrochloride
Placebo Oral Tablet
Sponsored by
Henrik Wiggers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Diabetes, Insulin resistance, Metformin, Hydralazine, Isosorbide Dinitrate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

General inclusion criteria for both H-HeFT and Met-HeFT

  • Patients with chronic heart failure
  • NYHA-class II, III or IV
  • LVEF </= 40% within 12 months prior to screening. The echocardiography should (i) be performed after uptitration in heart failure medication and (ii) LVEF from the most recently performed echocardiographic study should be used and (iii) LVEF must not be measured during rapid atrial fibrillation, i.e. heart rate >110/min) and (iiii) the echocardiography should be performed at least 3 months after CRT-implantation.
  • Patients should be uptitrated to recommended or maximally tolerated dose of ACE-I/ARB/ARNI (unless contraindicated) and beta-blocker (unless contraindicated). If indicated, an aldosterone receptor antagonist should be given (unless contraindicated).
  • A CRT device should be implanted, if indicated and accepted by the patient and patients with a CRT device should be treated for > 3 months.
  • Implantation of an ICD unit should be planned or already done, if indicated and accepted by the patient. The patient can be included in the study before a planned ICD implantation has been performed.
  • Informed consent

Specific inclusion criteria for only H-HeFT:

  • Systolic blood pressure ≥100 mmHg
  • NT-proBNP > 350 pg/ml or BNP > 80 pg/ml (in patients treated with ARNI, NT-proBNP must be used)

Specific inclusion criteria for only Met-HeFT:

Patients must have a diagnosis of type 2 diabetes or insulin resistance or diabetes risk. This includes 1 or more of any of the following:

  • A previous diagnosis of type 2 diabetes at any time without Metformin treatment during the last 3 months
  • HbA1c ≥ 5.5 % (≥ 37 mmol/mol) within 12 months prior to screening
  • Fasting P-glucose ≥ 5.6 mmol/l within 12 months prior to screening (measured when the patient in stable condition / has no intercurrent illness)
  • Body mass index ≥ 30 kg/m2
  • If oral glucose tolerance testing (OGTT) has been performed at any time prior to randomization: 2 hour P-glucose ≥ 7.8 mmol/l
  • In addition, patients in Met-HeFT must have eGFR ≥ 35 ml/min (MDRD)

Patients are randomized through an internet based randomization module. Patients can be allocated to a) both H-HeFT and Met-HeFT or to b) only H-HeFT or to c) only Met-HeFT.

Sites / Locations

  • Sygehus Sønderjylland, AabenraaRecruiting
  • Aalborg University HospitalRecruiting
  • Aarhus University HospitalRecruiting
  • Amager HospitalRecruiting
  • Bispebjerg HospitalRecruiting
  • Gentofte HospitalRecruiting
  • Glostrup HospitalRecruiting
  • Herlev HospitalRecruiting
  • Hvidovre HospitalRecruiting
  • RigshospitaletRecruiting
  • Sydvestjysk Sygehus, EsbjergRecruiting
  • Herning HospitalRecruiting
  • Nordsjællands Hospital HillerødRecruiting
  • Regionshospital Nordjylland, HjørringRecruiting
  • Holbæk HospitalRecruiting
  • Horsens HospitalRecruiting
  • Kolding HospitalRecruiting
  • Nykøbing Falster Hospital
  • Odense University HospitalRecruiting
  • Randers HospitalRecruiting
  • Sjællands Universitetshospital, RoskildeRecruiting
  • Silkeborg Hospital
  • Slagelse SygehusRecruiting
  • Vejle HospitalRecruiting
  • Viborg HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Hydralazine Isosorbide Dinitrate

Placebo (Hydralazine Isosorbide Dinitrate)

Metformin

Placebo (Metformin)

Arm Description

Tablet BiDil (Hydralazine 37.5 mg/ isosorbide dinitrate (ISDN) 20 mg) 2 tablets x 3 daily. Average treatment period 4 years.

Tablet Placebo 2 tablets x 3 daily. Average treatment period 4 years.

Tablet Metformin hydrochloride 500 mg 2 tablets x 2 daily (eGFR 35-60 ml/min: 500 mg x 2 daily). Average treatment period 4 years.

Tablet Placebo 500 mg 2 tablets x 2 daily (eGFR 35-60 ml/min: 500 mg x 2 daily). Average treatment period 4 years.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

H-HeFT secondary endpoint: Death
Death
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
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
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.
Met-HeFT secondary endpoint: Death
Death
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
Met-HeFT secondary endpoint: Acute myocardial infarction
Acute myocardial infarction
Met-HeFT secondary endpoint: Stroke
Stroke
Met-HeFT secondary endpoint: New onset type 2 diabetes
New onset type 2 diabetes
Met-HeFT secondary endpoint: Hospitalization or death caused by lactate acidosis.
Hospitalization or death caused by lactate acidosis.

Full Information

First Posted
February 20, 2018
Last Updated
May 30, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT03514108
Brief Title
DANHEART (H-HeFT and Met-HeFT)
Acronym
DANHEART
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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. The first hypothesis is that hydralazine in combination with isosorbide dinitrate can reduce mortality and hospitalization with worsening heart failure. The second hypothesis is that treatment of underlying insulin resistance/ type 2 diabetes with metformin in heart failure patients with moderately to severely reduced LVEF 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Diabetes
Keywords
Heart failure, Diabetes, Insulin resistance, Metformin, Hydralazine, Isosorbide Dinitrate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydralazine Isosorbide Dinitrate
Arm Type
Active Comparator
Arm Description
Tablet BiDil (Hydralazine 37.5 mg/ isosorbide dinitrate (ISDN) 20 mg) 2 tablets x 3 daily. Average treatment period 4 years.
Arm Title
Placebo (Hydralazine Isosorbide Dinitrate)
Arm Type
Placebo Comparator
Arm Description
Tablet Placebo 2 tablets x 3 daily. Average treatment period 4 years.
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Tablet Metformin hydrochloride 500 mg 2 tablets x 2 daily (eGFR 35-60 ml/min: 500 mg x 2 daily). Average treatment period 4 years.
Arm Title
Placebo (Metformin)
Arm Type
Placebo Comparator
Arm Description
Tablet Placebo 500 mg 2 tablets x 2 daily (eGFR 35-60 ml/min: 500 mg x 2 daily). Average treatment period 4 years.
Intervention Type
Drug
Intervention Name(s)
Hydralazine Isosorbide Dinitrate
Other Intervention Name(s)
BiDil
Intervention Description
Tablet BiDil (Hydralazine 37.5 mg/ Isosorbide Dinitrate (ISDN) 20 mg) 2 tablets x 3 daily
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
2 tablets x 3 daily
Intervention Type
Drug
Intervention Name(s)
Metformin Hydrochloride
Intervention Description
Tablet Metformin hydrochloride 500 mg 2 tablets x 2 daily (eGFR 35-60 ml/min: 500 mg x 2 daily)
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
2 tablets x 2 daily (eGFR 35-60 ml/min: 500 mg x 2 daily)
Primary Outcome Measure Information:
Title
H-HeFT combined endpoint: Death or hospitalization with worsening heart failure or urgent heart failure visit
Description
Death or hospitalization with worsening heart failure or urgent heart failure visit resulting in intravenous therapy or metolazone treatment for heart failure.
Time Frame
Through study completion, an average of 4 years
Title
Met-HeFT combined endpoint: Death or hospitalization with worsening heart failure or acute myocardial infarction or stroke or urgent heart failure visit
Description
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
Time Frame
Through study completion, an average of 4 years
Secondary Outcome Measure Information:
Title
H-HeFT secondary endpoint: Death
Description
Death
Time Frame
Through study completion, an average of 4 years
Title
H-HeFT secondary endpoint: Hospitalization with worsening heart failure or urgent visit resulting in intravenous therapy or metolazone therapy for heart failure
Description
Hospitalization with worsening heart failure or urgent visit resulting in intravenous therapy or metolazone therapy for heart failure
Time Frame
Through study completion, an average of 4 years
Title
H-HeFT secondary endpoint: Combined endpoint: Death or cardiovascular hospitalization or urgent heart failure visit
Description
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
Time Frame
Through study completion, an average of 4 years
Title
Met-HeFT secondary endpoint: Extended clinical endpoint: The primary endpoint or coronary revascularization or non-coronary revascularization or limb amputation.
Description
Extended clinical endpoint: The primary endpoint or coronary revascularization or non-coronary revascularization or limb amputation.
Time Frame
Through study completion, an average of 4 years
Title
Met-HeFT secondary endpoint: Death
Description
Death
Time Frame
Through study completion, an average of 4 years
Title
Met-HeFT secondary endpoint: Hospitalization with worsening heart failure or urgent visit resulting in intravenous therapy or metolazone therapy for heart failure
Description
Hospitalization with worsening heart failure or urgent visit resulting in intravenous therapy or metolazone therapy for heart failure
Time Frame
Through study completion, an average of 4 years
Title
Met-HeFT secondary endpoint: Acute myocardial infarction
Description
Acute myocardial infarction
Time Frame
Through study completion, an average of 4 years
Title
Met-HeFT secondary endpoint: Stroke
Description
Stroke
Time Frame
Through study completion, an average of 4 years
Title
Met-HeFT secondary endpoint: New onset type 2 diabetes
Description
New onset type 2 diabetes
Time Frame
Through study completion, an average of 4 years
Title
Met-HeFT secondary endpoint: Hospitalization or death caused by lactate acidosis.
Description
Hospitalization or death caused by lactate acidosis.
Time Frame
Through study completion, an average of 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: General inclusion criteria for both H-HeFT and Met-HeFT Patients with chronic heart failure NYHA-class II, III or IV LVEF </= 40% within 12 months prior to screening. The echocardiography should (i) be performed after uptitration in heart failure medication and (ii) LVEF from the most recently performed echocardiographic study should be used and (iii) LVEF must not be measured during rapid atrial fibrillation, i.e. heart rate >110/min) and (iiii) the echocardiography should be performed at least 3 months after CRT-implantation. Patients should be uptitrated to recommended or maximally tolerated dose of ACE-I/ARB/ARNI (unless contraindicated) and beta-blocker (unless contraindicated). If indicated, an aldosterone receptor antagonist should be given (unless contraindicated). A CRT device should be implanted, if indicated and accepted by the patient and patients with a CRT device should be treated for > 3 months. Implantation of an ICD unit should be planned or already done, if indicated and accepted by the patient. The patient can be included in the study before a planned ICD implantation has been performed. Informed consent Specific inclusion criteria for only H-HeFT: Systolic blood pressure ≥100 mmHg NT-proBNP > 350 pg/ml or BNP > 80 pg/ml (in patients treated with ARNI, NT-proBNP must be used) Specific inclusion criteria for only Met-HeFT: Patients must have a diagnosis of type 2 diabetes or insulin resistance or diabetes risk. This includes 1 or more of any of the following: A previous diagnosis of type 2 diabetes at any time without Metformin treatment during the last 3 months HbA1c ≥ 5.5 % (≥ 37 mmol/mol) within 12 months prior to screening Fasting P-glucose ≥ 5.6 mmol/l within 12 months prior to screening (measured when the patient in stable condition / has no intercurrent illness) Body mass index ≥ 30 kg/m2 If oral glucose tolerance testing (OGTT) has been performed at any time prior to randomization: 2 hour P-glucose ≥ 7.8 mmol/l In addition, patients in Met-HeFT must have eGFR ≥ 35 ml/min (MDRD) Patients are randomized through an internet based randomization module. Patients can be allocated to a) both H-HeFT and Met-HeFT or to b) only H-HeFT or to c) only Met-HeFT.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik Wiggers, MD, PhD
Phone
+45 40136627
Email
henrikwiggers@dadlnet.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Wiggers, MD, PhD
Organizational Affiliation
Dept. of Cardiology, Aarhus University Hospital, Aarhus, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lars Køber, MD, PhD
Organizational Affiliation
Dept. of Cardiology, Rigshospitalet, Copenhagen, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Finn Gustafsson, MD, PhD
Organizational Affiliation
Dept. of Cardiology, Rigshospitalet, Copenhagen, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Søren Mellemkjaer, MD, PhD
Organizational Affiliation
Dept. of Cardiology, Aarhus University Hospital, Aarhus, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gunnar Gislason, MD, PhD
Organizational Affiliation
The Danish Heart Foundation, Copenhagen, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Sygehus Sønderjylland, Aabenraa
City
Aabenraa
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bartlomiej Jonczy
Facility Name
Aalborg University Hospital
City
Aalborg
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Søren Vraa
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Wiggers
Phone
+45 40136627
Email
henrikwiggers@dadlnet.dk
First Name & Middle Initial & Last Name & Degree
Anders Jorsal
Facility Name
Amager Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Broennum-Schou
Facility Name
Bispebjerg Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olav Wendelbo Nielsen
Facility Name
Gentofte Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten Schou
Facility Name
Glostrup Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jawdat Abdulla
Facility Name
Herlev Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten Schou
Facility Name
Hvidovre Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anette Sjøl
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Køber
First Name & Middle Initial & Last Name & Degree
Finn Gustafsson
Facility Name
Sydvestjysk Sygehus, Esbjerg
City
Esbjerg
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Vilain Mikkelsen
Facility Name
Herning Hospital
City
Herning
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten Bøttcher
Facility Name
Nordsjællands Hospital Hillerød
City
Hillerød
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nis Stride
Facility Name
Regionshospital Nordjylland, Hjørring
City
Hjørring
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gitte Nielsen
Facility Name
Holbæk Hospital
City
Holbæk
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walter Bjørn Nielsen
Facility Name
Horsens Hospital
City
Horsens
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Kaae Dodt
Facility Name
Kolding Hospital
City
Kolding
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Petronela Poenaru
Facility Name
Nykøbing Falster Hospital
City
Nykøbing Falster
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisbeth Tingsted
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikael Kjær Poulsen
Facility Name
Randers Hospital
City
Randers
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiomars Mahboubi
Facility Name
Sjællands Universitetshospital, Roskilde
City
Roskilde
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niels Eske Bruun
Facility Name
Silkeborg Hospital
City
Silkeborg
Country
Denmark
Individual Site Status
Terminated
Facility Name
Slagelse Sygehus
City
Slagelse
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Mikkelsen
Facility Name
Vejle Hospital
City
Vejle
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vibeke Brogaard
Facility Name
Viborg Hospital
City
Viborg
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malene Hollingdal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33039340
Citation
Wiggers H, Kober L, Gislason G, Schou M, Poulsen MK, Vraa S, Nielsen OW, Bruun NE, Norrelund H, Hollingdal M, Barasa A, Bottcher M, Dodt K, Hansen VB, Nielsen G, Knudsen AS, Lomholdt J, Mikkelsen KV, Jonczy B, Bronnum-Schou J, Poenaru MP, Abdulla J, Raymond I, Mahboubi K, Sillesen K, Serup-Hansen K, Madsen JS, Kristensen SL, Larsen AH, Botker HE, Torp-Petersen C, Eiskjaer H, Moller J, Hassager C, Steffensen FH, Bibby BM, Refsgaard J, Hofsten DE, Mellemkjaer S, Gustafsson F. The DANish randomized, double-blind, placebo controlled trial in patients with chronic HEART failure (DANHEART): A 2 x 2 factorial trial of hydralazine-isosorbide dinitrate in patients with chronic heart failure (H-HeFT) and metformin in patients with chronic heart failure and diabetes or prediabetes (Met-HeFT). Am Heart J. 2021 Jan;231:137-146. doi: 10.1016/j.ahj.2020.09.020. Epub 2020 Oct 9.
Results Reference
derived

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DANHEART (H-HeFT and Met-HeFT)

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