Back to Search
Start Over
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)☆
- Source :
- American Heart Journal, Wiggers, H, Køber, L, Gislason, G, Schou, M, Poulsen, M K, Vraa, S, Nielsen, O W, Bruun, N E, Nørrelund, H, Hollingdal, M, Barasa, A, Bøttcher, M, Dodt, K, Hansen, V B, Nielsen, G, Knudsen, A S, Lomholdt, J, Mikkelsen, K V, Jonczy, B, Brønnum-Schou, J, Poenaru, M P, Abdulla, J, Raymond, I, Mahboubi, K, Sillesen, K, Serup-Hansen, K, Madsen, J S, Kristensen, S L, Larsen, A H, Bøtker, H E, Torp-Petersen, C, Eiskjær, H, Møller, J, Hassager, C, Steffensen, F H, Bibby, B M, Refsgaard, J, Høfsten, D E, Mellemkjær, S & Gustafsson, F 2021, ' The DANish randomized, double-blind, placebo controlled trial in patients with chronic HEART failure (DANHEART) : A 2 × 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) ', American Heart Journal, vol. 231, pp. 137-146 . https://doi.org/10.1016/j.ahj.2020.09.020, Wiggers, H, Køber, L, Gislason, G, Schou, M, Poulsen, M K, Vraa, S, Nielsen, O W, Bruun, N E, Nørrelund, H, Hollingdal, M, Barasa, A, Bøttcher, M, Dodt, K, Hansen, V B, Nielsen, G, Knudsen, A S, Lomholdt, J, Mikkelsen, K V, Jonczy, B, Brønnum-Schou, J, Poenaru, M P, Abdulla, J, Raymond, I, Mahboubi, K, Sillesen, K, Serup-Hansen, K, Madsen, J S, Kristensen, S L, Larsen, A H, Bøtker, H E, Torp-Petersen, C, Eiskjær, H, Møller, J, Hassager, C, Steffensen, F H, Bibby, B M, Refsgaard, J, Høfsten, D E, Mellemkjær, S & Gustafsson, F 2021, ' The DANish randomized, double-blind, placebo controlled trial in patients with chronic HEART failure (DANHEART) : A 2 × 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) ', American Heart Journal, vol. 231, pp. 137-146 . https://doi.org/10.1016/j.ahj.2020.09.020, https://doi.org/10.1016/j.ahj.2020.09.020
- Publication Year :
- 2020
- Publisher :
- Elsevier Inc., 2020.
-
Abstract
- OBJECTIVES: The DANHEART trial is a multicenter, randomized (1:1), parallel-group, double-blind, placebo-controlled study in chronic heart failure patients with reduced ejection fraction (HFrEF). This investigator driven study will include 1500 HFrEF patients and test in a 2 × 2 factorial design: 1) if hydralazine-isosorbide dinitrate reduces the incidence of death and hospitalization with worsening heart failure vs. placebo (H-HeFT) and 2) if metformin reduces the incidence of death, worsening heart failure, acute myocardial infarction, and stroke vs. placebo in patients with diabetes or prediabetes (Met-HeFT).METHODS: Symptomatic, optimally treated HFrEF patients with LVEF ≤40% are randomized to active vs. placebo treatment. Patients can be randomized in either both H-HeFT and Met-HeFT or to only one of these study arms. In this event-driven study, it is anticipated that 1300 patients should be included in H-HeFT and 1100 in Met-HeFT and followed for an average of 4 years.RESULTS: As of May 2020, 296 patients have been randomized at 20 centers in Denmark.CONCLUSION: The H-HeFT and Met-HeFT studies will yield new knowledge about the potential benefit and safety of 2 commonly prescribed drugs with limited randomized data in patients with HFrEF.
- Subjects :
- Male
medicine.medical_specialty
Denmark
Trial Designs
Placebo-controlled study
Myocardial Infarction
030204 cardiovascular system & hematology
Isosorbide Dinitrate
Placebo
GLUCOSE
Placebos
Prediabetic State
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Internal medicine
Diabetes mellitus
Diabetes Mellitus
EPIDEMIOLOGY
Medicine
Humans
Hypoglycemic Agents
030212 general & internal medicine
Prediabetes
Myocardial infarction
Stroke
Aged
Heart Failure
INSULIN-RESISTANCE
OUTCOMES
Ejection fraction
business.industry
MORTALITY
Stroke Volume
medicine.disease
Hydralazine
Metformin
Hospitalization
Drug Combinations
VASODILATOR THERAPY
Heart failure
Chronic Disease
Female
FOLLOW-UP
Cardiology and Cardiovascular Medicine
business
INTERVENTION
LOW-RISK
Subjects
Details
- Language :
- English
- ISSN :
- 10976744 and 00028703
- Database :
- OpenAIRE
- Journal :
- American Heart Journal
- Accession number :
- edsair.doi.dedup.....8d1e160357c3400540d64d48cbe0cd8c