DANHEART (H-HeFT and Met-HeFT) (NCT03514108) | Clinical Trial Compass
CompletedPhase 4
DANHEART (H-HeFT and Met-HeFT)
Denmark1,100 participantsStarted 2018-03-01
Plain-language 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.
1. The first hypothesis is that hydralazine in combination with isosorbide dinitrate can reduce mortality and hospitalization with worsening heart failure in chronic heart failure patients with reduced LVEF.
2. The second hypothesis is that treatment with metformin in chronic heart failure patients with reduced LVEF and type 2 diabetes / diabetes risk / insulin resistance 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since the DANHEART trial is now completed and was a Phase 4 study — meaning these drugs were already approved — has the published data from this trial changed your thinking about whether hydralazine-nitrate or metformin would be appropriate for my specific situation with heart failure and diabetes?
2The trial measured combined primary endpoints for both the H-HeFT and Met-HeFT arms, which often include outcomes like hospitalizations or death — can you walk me through what the results actually showed and whether they suggest a meaningful benefit or any unexpected risks for patients like me?
3Because this was a Phase 4 trial testing existing medications in a new combined heart failure and diabetes population, are there any safety signals from the DANHEART results that you think I should know about before considering either of these treatments?
4Would the findings from this trial change how you'd sequence or combine my current heart failure and diabetes medications, or is standard guideline-based therapy still the stronger starting point for my care?
5Given that the trial is completed and the results are available, is there anything about my specific health profile — such as my kidney function, blood pressure, or diabetes control — that would make the approaches tested in DANHEART a better or worse fit compared to other options you'd consider for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
H-HeFT combined primary endpoint
Timeframe: Through study completion, an average of 4 years
2
Met-HeFT combined primary endpoint
Timeframe: Through study completion, an average of 4 years