Heart Failure, SystolicPhase 1NCT03122769
Cardiac Uptake of Metformin, Visualized by Positron Emission Tomography
A Phase 1 study testing 11C-metformin in people with Heart Failure, Systolic, run by Henrik Wiggers at 1 site in Denmark.
Trial summary
The purpose of the study is to evaluate if metformin is taken up into the failing myocardium. Recent experimental and epidemiological studies have shown beneficial effects of metformin on heart failure. It is unknown whether this effect is direct or indirect. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- 11C-metformin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2017to 10 Apr 2018
- Phase
- Phase 1
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic heart failure, Left Ventricular Ejection Fraction <45%
- New York Heart Association (NYHA) class I, II, III
- Relatively preserved renal function (eGFR > 30 ml/min)
- Ability to understand the written patient information and to give informed consent
- Negative p-HCG for women of childbearing potential
Who cannot join
- Known allergy to metformin
- 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: Cardiac Uptake of Metformin and Expression of Metformin Membrane Transporter Proteins in the Human Failing Myocardium
The purpose of the study is to evaluate if metformin is taken up into the failing myocardium. Recent experimental and epidemiological studies have shown beneficial effects of metformin on heart failure. It is unknown whether this effect is direct or indirect.
The aim of the study is to investigate if metformin is taken up in heart failure using a novel 11C-metformin tracer and positron emission tomography (PET).
- Conditions
- Heart Failure, Systolic
- Being tested
- 11C-metformin
- Keywords
- Metformin, Heart Failure, Organic cation transporter, Pharmacogenetics, Pharmacokinetics, Positron Emission Tomography
- Medical subject headings
- Heart Failure, Systolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-metforminRadiation
200 MBq of 11C-metformin is injected in the cubital vein. The participant is then scanned for 120 min using Positron Emission Tomography
| Study group | Role | What they receive |
|---|---|---|
| 11C-metformin | Experimental | All participants allocated to the study will be included in this arm Receives: Radiation: 11C-metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metformin uptake in the failing myocardium
Cardiac uptake is evaluated through analysis of acquired PET-images.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Dec 2017
- Primary completion10 Apr 2018
- Study completion10 Apr 2018
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All 6 subjects allocated to the study will receive 11C-metformin intravenously.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henrik Wiggers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henrik Wiggers, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122769
- Sponsor's protocol ID
- 2016-003453-15
- Other IDs
- 2016
- Status last verified
- Apr 2018
- First submitted
- 18 Apr 2017
- Last updated
- 20 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Larsen AH, Lin L, Moller AB, Farup J, Tolbod LP, Billeskov T, Brorson J, Sundelin EIO, Jakobsen S, Norrelund H, Harms HJ, Hansson NH, Pedersen SB, Gormsen LC, Luo Y, de Paoli FV, Frokiaer J, Wiggers H, Jessen N. Metformin inhibits proliferation of residing fibroadipogenic progenitor cells from failing human hearts. ESC Heart Fail. 2026 Feb 3;13(1):xvag001. doi: 10.1093/eschf/xvag001.
PubMed 41711740
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
- Cardiac Uptake of Metformin and Expression of Metformin Membrane Transporter Proteins in the Human Failing Myocardium
- ClinicalTrials.gov ID
- NCT03122769
- Acronym / sponsor ID
- 2016-003453-15
- Conditions
- Heart Failure, Systolic
- Keywords
- Metformin, Heart Failure, Organic cation transporter, Pharmacogenetics, Pharmacokinetics, Positron Emission Tomography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Henrik WiggersUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 21 Apr 2017 (actual)
- 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 purpose of the study is to evaluate if metformin is taken up into the failing myocardium. Recent experimental and epidemiological studies have shown beneficial effects of metformin on heart failure. It is unknown whether this effect is direct or indirect.
The aim of the study is to investigate if metformin is taken up in heart failure using a novel 11C-metformin tracer and positron emission tomography (PET).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All 6 subjects allocated to the study will receive 11C-metformin intravenously.
| Arm | Type | Receives |
|---|---|---|
| 11C-metformin | Experimental | Radiation: 11C-metforminAll participants allocated to the study will be included in this arm |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with chronic heart failure, Left Ventricular Ejection Fraction <45%
- New York Heart Association (NYHA) class I, II, III
- Relatively preserved renal function (eGFR > 30 ml/min)
- Ability to understand the written patient information and to give informed consent
- Negative p-HCG for women of childbearing potential
Key exclusion criteria (3 listed)
- Known allergy to metformin
- 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 |
|---|---|---|
| 11C-metformin200 MBq of 11C-metformin is injected in the cubital vein. The participant is then scanned for 120 min using Positron Emission Tomography | Radiation | 11C-metformin |
Primary outcome
Metformin uptake in the failing myocardium
Time frame: 12 months
Cardiac uptake is evaluated through analysis of acquired PET-images.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Derived from this study: PubMed 41711740Larsen AH, Lin L, Moller AB, Farup J, Tolbod LP, Billeskov T, Brorson J, Sundelin EIO, Jakobsen S, Norrelund H, Harms HJ, Hansson NH, Pedersen SB, Gormsen LC, Luo Y, de Paoli FV, Frokiaer J, Wiggers H, Jessen N. Metformin inhibits proliferation of residing fibroadipogenic progenitor cells from failing human hearts. ESC Heart Fail. 2026 Feb 3;13(1):xvag001. doi: 10.1093/eschf/xvag001.
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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 1 study testing 11C-metformin in people with Heart Failure, Systolic, run by Henrik Wiggers 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 5 inclusion and 3 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: finished, 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Metformin uptake in the failing myocardium (time frame: 12 months). 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 NCT03122769, 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; AzTrials last refreshed its copy on 6 Nov 2026.