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

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ClinicalTrials.gov Identifier: NCT02797340
Recruitment Status : Active, not recruiting
First Posted : June 13, 2016
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Henrik Wiggers, Aarhus University Hospital

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.


Condition or disease Intervention/treatment Phase
Heart Failure, Systolic Other: Blood draws and urine samples for metformin concentration measurements Drug: Metformin Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Metformin in Patients With Chronic and Acute Heart Failure: Pharmacokinetics and Polymorphisms in Genes Encoding Membrane Metformin Transporter Proteins
Actual Study Start Date : January 11, 2016
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Interventional
All participants
Other: Blood draws and urine samples for metformin concentration measurements
Drug: Metformin



Primary Outcome Measures :
  1. Changes in renal clearance of metformin between patients with acute and chronic heart failure. [ Time Frame: approximately 2 weeks ]
  2. Mean trough steady-state concentrations of metformin with emphasis on the intra-interindividual variability in HF patients [ Time Frame: 3 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797340


Locations
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Denmark
Aarhus University Hospital, Department of Cardiology, Palle Juul-Jensens Boulevard 99
Aarhus N, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital

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Responsible Party: Henrik Wiggers, Senior consultant, associate professor, PhD, DMSc, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02797340     History of Changes
Other Study ID Numbers: 50268-20150921
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs