Metformin in patients with chronic and acute heart failure: Pharmacokinetics and polymorphisms in genes encoding membrane metformin transporter proteins

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001513-25-DK

Enrollment

162

Registered

2016-04-27

Start date

2016-05-12

Completion date

Unknown

Last updated

2018-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 19.0 Level: LLT Classification code 10000803 Term: Acute heart failure System Organ Class: 100000004849 MedDRA version: 19.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849

Interventions

Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Metformin Other descriptive name: METFORMIN HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: range Concentration numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Substudy A: • Patients with decompensated heart failure • Increased need for diuretics as judged by the clinicians • LVEF 1 month) • Stable dosage of metformin treatment for at least 1 week prior to examination Substudy B: • Patients with heart failure • LVEF 1 month) • Stable dosage of metformin treatment for at least 1 week prior to examination Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 82

Exclusion criteria

Exclusion criteria: Substudy A: • Severe cardiac failure, defined as o systolic blood pressure continuously < 85 mmHg o signs of tissue hypoperfusion (oliguria < 30 mL/h, altered level of consciousness, rapid deterioration of kidney function) o Need for intravenous inotropic support • Age < 18 years • Current abuse of alcohol or drugs • Adjustment or discontinuation of metformin dose during admission before examination Substudy B: • Age < 18 years • Current abuse of alcohol or drugs

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the pharmacokinetics of metformin in type 2 diabetic patients with heart failure in acute and chronic state. To investigate the influence of polymorphisms in genes encoding the metformin transporter proteins on metformin trough levels in type 2 diabetic heart failure patients.;Secondary Objective: Not applicable;Primary end point(s): Substudy A: Changes in renal clearance of metformin between patients with acute and chronic heart failure. Substudy B: Mean trough steady-state concentrations (Css,min) of metformin with emphasis on the intra-interindividual variability in heart failure patients.;Timepoint(s) of evaluation of this end point: At End of trial: LVLS	—

Measure

Time frame

Main Objective: To compare the pharmacokinetics of metformin in type 2 diabetic patients with heart failure in acute and chronic state. To investigate the influence of polymorphisms in genes encoding the metformin transporter proteins on metformin trough levels in type 2 diabetic heart failure patients.;Secondary Objective: Not applicable;Primary end point(s): Substudy A: Changes in renal clearance of metformin between patients with acute and chronic heart failure. Substudy B: Mean trough steady-state concentrations (Css,min) of metformin with emphasis on the intra-interindividual variability in heart failure patients.;Timepoint(s) of evaluation of this end point: At End of trial: LVLS

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Denmark

Contacts

Public ContactAnders Hostrup Larsen

Aarhus University Hospital

andelars@rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026