Heart Failure, SystolicPhase 4MetKinNCT02797340
Metformin Pharmacokinetics in Patients With Chronic and Acute Heart Failure
A Phase 4 study testing Blood draws and urine samples for metformin concentration measurements and Metformin in people with Heart Failure, Systolic, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- Blood draws and urine samples for metformin concentration measurements and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Jan 2016to 30 Apr 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- Current abuse of alcohol or drugs
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Department of Cardiology, Palle Juul-Jensens Boulevard 99
Aarhus N, 8200
About this study
Official title: Metformin in Patients With Chronic and Acute Heart Failure: Pharmacokinetics and Polymorphisms in Genes Encoding Membrane Metformin Transporter Proteins
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.
Read the 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:
- To compare the pharmacokinetics of metformin in 12 diabetic patients with HF in acute and chronic state.
- 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.
- Conditions
- Heart Failure, Systolic
- Being tested
- Blood draws and urine samples for metformin concentration measurements, Metformin
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draws and urine samples for metformin concentration measurementsOther
MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | All participants Receives: Other: Blood draws and urine samples for metformin concentration measurements; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in renal clearance of metformin between patients with acute and chronic heart failure.
Measured: approximately 2 weeks
Mean trough steady-state concentrations of metformin with emphasis on the intra-interindividual variability in HF patients
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study start11 Jan 2016
- Primary completion30 Apr 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Wiggers, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797340
- Sponsor's protocol ID
- 50268-20150921
- Acronym
- MetKin
- Status last verified
- Apr 2018
- First submitted
- 8 Jun 2016
- Last updated
- 20 Apr 2018
- Results posted
- No
Publications
Larsen AH, Stage TB, Christensen MMH, Feddersen S, Nielsen F, Norrelund H, Frokiaer J, Jessen N, Brosen K, Wiggers H. Metformin Pharmacogenetics in Heart Failure Patients with Reduced Ejection Fraction: Impact on Metformin and Growth Differentiation Factor-15 Plasma Levels. Clin Pharmacokinet. 2026 Sep 28. doi: 10.1007/s40262-026-01699-1. Online ahead of print.
PubMed 42804152
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin in Patients With Chronic and Acute Heart Failure: Pharmacokinetics and Polymorphisms in Genes Encoding Membrane Metformin Transporter Proteins
- ClinicalTrials.gov ID
- NCT02797340
- Acronym / sponsor ID
- MetKin / 50268-20150921
- Conditions
- Heart Failure, Systolic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To compare the pharmacokinetics of metformin in 12 diabetic patients with HF in acute and chronic state.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: Blood draws and urine samples for metformin concentration measurements, Drug: MetforminAll participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- Age < 18 years
- Current abuse of alcohol or drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draws and urine samples for metformin concentration measurements | Other | Interventional |
| Metformin | Drug | Interventional |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Derived from this study: PubMed 42804152Larsen AH, Stage TB, Christensen MMH, Feddersen S, Nielsen F, Norrelund H, Frokiaer J, Jessen N, Brosen K, Wiggers H. Metformin Pharmacogenetics in Heart Failure Patients with Reduced Ejection Fraction: Impact on Metformin and Growth Differentiation Factor-15 Plasma Levels. Clin Pharmacokinet. 2026 Sep 28. doi: 10.1007/s40262-026-01699-1. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood draws and urine samples for metformin concentration measurements and Metformin in people with Heart Failure, Systolic, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in renal clearance of metformin between patients with acute and chronic heart failure. (time frame: approximately 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02797340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.