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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03122769
Date of registration: 18/04/2017
Prospective Registration: Yes
Primary sponsor: Henrik Wiggers
Public title: Cardiac Uptake of Metformin, Visualized by Positron Emission Tomography
Scientific title: Cardiac Uptake of Metformin and Expression of Metformin Membrane Transporter Proteins in the Human Failing Myocardium
Date of first enrolment: December 1, 2017
Target sample size: 6
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03122769
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
Denmark
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- Known allergy to metformin

- Age < 18 years

- Current abuse of alcohol or drugs



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All
Health Condition(s) or Problem(s) studied
Heart Failure, Systolic
Intervention(s)
Radiation: 11C-metformin
Primary Outcome(s)
Metformin uptake in the failing myocardium [Time Frame: 12 months]
Secondary Outcome(s)
Secondary ID(s)
2016-003453-15
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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