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Metformin Pharmacokinetics in Patients With Chronic and Acute Heart Failure (MetKin)

Primary Purpose

Heart Failure, Systolic

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Blood draws and urine samples for metformin concentration measurements
Metformin
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure, Systolic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age < 18 years
  • Current abuse of alcohol or drugs

Sites / Locations

  • Aarhus University Hospital, Department of Cardiology, Palle Juul-Jensens Boulevard 99

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional

Arm Description

All participants

Outcomes

Primary Outcome Measures

Changes in renal clearance of metformin between patients with acute and chronic heart failure.
Mean trough steady-state concentrations of metformin with emphasis on the intra-interindividual variability in HF patients

Secondary Outcome Measures

Full Information

First Posted
June 8, 2016
Last Updated
April 19, 2018
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02797340
Brief Title
Metformin Pharmacokinetics in Patients With Chronic and Acute Heart Failure
Acronym
MetKin
Official Title
Metformin in Patients With Chronic and Acute Heart Failure: Pharmacokinetics and Polymorphisms in Genes Encoding Membrane Metformin Transporter Proteins
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 11, 2016 (Actual)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
April 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

5. Study Description

Brief Summary
The study evaluates the pharmacokinetics of metformin in heart failure patients in acute and chronic state in relation to metformin transporter genotypes. Participants have heart failure and type 2 diabetes treated with metformin. Hypothesis: Primary: The renal clearance of metformin is decreased in acute state of congestive heart failure compared with chronic state. Secondary: Metformin trough values in HF patients are influenced by polymorphisms in transporter genes relevant to the pharmacokinetics of metformin.
Detailed Description
Background: Heart failure (HF) is a common disease and diabetes/insulin resistance are present in approximately 50 % of HF patients. Metformin is the most commonly prescribed oral anti-diabetic drug, and a huge inter-individual variability in trough steady-state metformin concentration in type 2 diabetics have been demonstrated. Genetic polymorphisms in metformin transporter genes are likely to have a direct impact on metformin pharmacokinetics and variability in drug responses, but the influence of polymorphisms in these transporter genes on circulating metformin levels is presently unknown in HF patients. Objectives: A) To compare the pharmacokinetics of metformin in 12 diabetic patients with HF in acute and chronic state. B) To investigate the influence of polymorphisms in genes encoding the metformin transporter proteins on metformin trough levels in 150 diabetic HF patients. Design: An open, single-center study enrolling 12 patients with acute heart failure (study A) and 150 patients with stable chronic heart failure (study B). The participants have diabetes already treated with metformin prior to inclusion. Through repeated blood draws, the concentration of metformin will be determined along with genotyping for metformin transporter genes. Primary outcome: Study A: Changes in renal clearance of metformin between patients with acute and chronic heart failure. Study B: Mean trough steady-state concentrations of metformin with emphasis on the intra-interindividual variability in HF patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
All participants
Intervention Type
Other
Intervention Name(s)
Blood draws and urine samples for metformin concentration measurements
Intervention Type
Drug
Intervention Name(s)
Metformin
Primary Outcome Measure Information:
Title
Changes in renal clearance of metformin between patients with acute and chronic heart failure.
Time Frame
approximately 2 weeks
Title
Mean trough steady-state concentrations of metformin with emphasis on the intra-interindividual variability in HF patients
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Age < 18 years Current abuse of alcohol or drugs
Facility Information:
Facility Name
Aarhus University Hospital, Department of Cardiology, Palle Juul-Jensens Boulevard 99
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

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Metformin Pharmacokinetics in Patients With Chronic and Acute Heart Failure

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