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

Phase 1

Conditions: MedDRA version: 19.0Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 100000004849
MedDRA version: 19.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2016-001513-25-DK

Lead Sponsor: Aarhus University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 162

Inclusion Criteria

Substudy A:
•Patients with decompensated heart failure
•Increased need for diuretics as judged by the clinicians
•LVEF < 45% measured during admission or within 12 months prior to inclusion
•NYHA-class I, II, III or IV
•Ability to understand the written patient information and to give informed consent
•Diabetes Type 2 (and in metformin treatment for > 1 month)
•Stable dosage of metformin treatment for at least 1 week prior to examination

Substudy B:
•Patients with heart failure
•LVEF < 45% within 12 months prior to inclusion
•NYHA-class I, II, III or IV
•Ability to understand the written patient information and to give informed consent
•Diabetes Type 2 (and in metformin treatment for > 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

Substudy A:
•Severe cardiac failure, defined as
osystolic blood pressure continuously < 85 mmHg
osigns of tissue hypoperfusion (oliguria < 30 mL/h, altered level of consciousness, rapid deterioration of kidney function)
oNeed 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