Metformin Pharmacokinetics in Patients With Chronic and Acute Heart Failure (MetKin)
|ClinicalTrials.gov Identifier: NCT02797340|
Recruitment Status : Active, not recruiting
First Posted : June 13, 2016
Last Update Posted : April 20, 2018
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.
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|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Other: Blood draws and urine samples for metformin concentration measurements
- Changes in renal clearance of metformin between patients with acute and chronic heart failure. [ Time Frame: approximately 2 weeks ]
- Mean trough steady-state concentrations of metformin with emphasis on the intra-interindividual variability in HF patients [ Time Frame: 3 weeks ]
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
|Aarhus University Hospital, Department of Cardiology, Palle Juul-Jensens Boulevard 99|
|Aarhus N, Denmark, 8200|