DANHEART (H-HeFT and Met-HeFT)

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    1500
  • sponsor
    Henrik Wiggers
Updated on 6 October 2021
diabetes
insulin
body mass index
heart failure
fasting
systolic blood pressure
type 2 diabetes mellitus
oral glucose tolerance test
insulin resistance
aldosterone
beta blockers
chronic heart failure
nt-probnp
b-type natriuretic peptide
metformin
hemoglobin a1c
glycosylated hemoglobin
beta-adrenergic blocking agents
aldosterone antagonists
angiotensin ii receptor antagonists
hydralazine

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.
  2. 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 NIDDM, Diabetes Mellitus, Heart failure, Heart disease, Diabetes Mellitus, Type 2, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Congestive Heart Failure, Cardiac Disease, Diabetes Mellitus Type 2, Diabetes, type 2 diabetes mellitus, diabetes mellitus (dm), cardiac failure, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2, congestive heart disease
Treatment Metformin Hydrochloride, Placebo Oral Tablet, Hydralazine Isosorbide Dinitrate
Clinical Study IdentifierNCT03514108
SponsorHenrik Wiggers
Last Modified on6 October 2021

Eligibility

Yes No Not Sure

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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