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Can two old drugs save heart failure patients?

NCT ID NCT03514108

Disease control Sponsor: Henrik Wiggers Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two drugs—hydralazine-ISDN and metformin—in 1100 people with chronic heart failure and reduced heart function. Some participants also had diabetes or insulin resistance. The goal was to see if these drugs could lower the risk of death or hospital stays due to worsening heart failure. The study was double-blind and placebo-controlled, meaning neither patients nor doctors knew who got the real drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1,100 people

The number who actually took part.

Started

Mar 2018

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

congestive heart failure diabetes mellitus heart failure Insulin Resistance type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes Heart failure

Contacts and locations

Locations

  • 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

  • Herning Hospital

    Herning, Denmark

  • Holbæk Hospital

    Holbæk, Region Sjælland, Denmark

  • Holbæk Hospital

    Holbæk, Denmark

  • Horsens Hospital

    Horsens, Denmark

  • Hvidovre Hospital

    Copenhagen, Denmark

  • Kolding Hospital

    Kolding, Denmark

  • Nordsjællands Hospital Hillerød

    Hillerød, Denmark

  • Nykøbing Falster Hospital

    Nykøbing Falster, Denmark

  • Odense University Hospital

    Odense, Denmark

  • Randers Hospital

    Randers, Denmark

  • Regionshospital Nordjylland, Hjørring

    Hjørring, Denmark

  • Rigshospitalet

    Copenhagen, Denmark

  • Silkeborg Hospital

    Silkeborg, Denmark

  • Sjællands Universitetshospital, Roskilde

    Roskilde, Denmark

  • Slagelse Sygehus

    Slagelse, Denmark

  • Sydvestjysk Sygehus, Esbjerg

    Esbjerg, Denmark

  • Sygehus Sønderjylland, Aabenraa

    Aabenraa, Denmark

  • Vejle Hospital

    Vejle, Denmark

  • Viborg Hospital

    Viborg, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.