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) (DANHEART)
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- STATUS
- Recruiting
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- End date
- Dec 31, 2026
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- participants needed
- 1500
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- sponsor
- Henrik Wiggers
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.
Details
| Condition | Heart Failure, Diabetes |
|---|---|
| Treatment | Metformin Hydrochloride, Placebo Oral Tablet, Hydralazine Isosorbide Dinitrate |
| Clinical Study Identifier | NCT03514108 |
| Sponsor | Henrik Wiggers |
| Last Modified on | 23 October 2022 |
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