Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03122769 |
Date of registration:
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18/04/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Cardiac Uptake of Metformin, Visualized by Positron Emission Tomography
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Scientific title:
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Cardiac Uptake of Metformin and Expression of Metformin Membrane Transporter Proteins in the Human Failing Myocardium |
Date of first enrolment:
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December 1, 2017 |
Target sample size:
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6 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03122769 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Denmark
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Heart Failure, Systolic
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Intervention(s)
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Radiation: 11C-metformin
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Primary Outcome(s)
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Metformin uptake in the failing myocardium
[Time Frame: 12 months]
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Secondary ID(s)
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2016-003453-15
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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