Phase
Condition
Congestive Heart Failure
Diabetic Neuropathy
Heart Failure
Treatment
Hydralazine Isosorbide Dinitrate
Metformin Hydrochloride
Placebo Oral Tablet
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
General inclusion criteria for both H-HeFT and Met-HeFT
Patients with chronic heart failure
NYHA-class II, III or IV
LVEF 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.
Study Design
Connect with a study center
Holbæk Hospital
Holbæk, Region Sjælland
DenmarkActive - Recruiting
Sygehus Sønderjylland, Aabenraa
Aabenraa,
DenmarkActive - Recruiting
Aalborg University Hospital
Aalborg,
DenmarkActive - Recruiting
Aarhus University Hospital
Aarhus,
DenmarkActive - Recruiting
Amager Hospital
Copenhagen,
DenmarkActive - Recruiting
Bispebjerg Hospital
Copenhagen,
DenmarkActive - Recruiting
Gentofte Hospital
Copenhagen,
DenmarkActive - Recruiting
Glostrup Hospital
Copenhagen,
DenmarkActive - Recruiting
Herlev Hospital
Copenhagen,
DenmarkActive - Recruiting
Hvidovre Hospital
Copenhagen,
DenmarkActive - Recruiting
Rigshospitalet
Copenhagen,
DenmarkActive - Recruiting
Sydvestjysk Sygehus, Esbjerg
Esbjerg,
DenmarkActive - Recruiting
Herning Hospital
Herning,
DenmarkActive - Recruiting
Nordsjællands Hospital Hillerød
Hillerød,
DenmarkActive - Recruiting
Regionshospital Nordjylland, Hjørring
Hjørring,
DenmarkActive - Recruiting
Horsens Hospital
Horsens,
DenmarkActive - Recruiting
Kolding Hospital
Kolding,
DenmarkActive - Recruiting
Nykøbing Falster Hospital
Nykøbing Falster,
DenmarkSite Not Available
Odense University Hospital
Odense,
DenmarkActive - Recruiting
Randers Hospital
Randers,
DenmarkActive - Recruiting
Sjællands Universitetshospital, Roskilde
Roskilde,
DenmarkActive - Recruiting
Silkeborg Hospital
Silkeborg,
DenmarkTerminated
Slagelse Sygehus
Slagelse,
DenmarkActive - Recruiting
Vejle Hospital
Vejle,
DenmarkActive - Recruiting
Viborg Hospital
Viborg,
DenmarkActive - Recruiting
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