Back to resultsCardiac Uptake of Metformin, Visualized by Positron Emission Tomography
Primary Purpose
Heart Failure, Systolic
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
11C-metformin
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Systolic focused on measuring Metformin, Heart Failure, Organic cation transporter, Pharmacogenetics, Pharmacokinetics, Positron Emission Tomography
Eligibility 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
Sites / Locations
- Aarhus University Hospital, Department of Cardiology, Palle Juul-Jensens Boulevard 99
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
11C-metformin
Arm Description
All participants allocated to the study will be included in this arm
Outcomes
Primary Outcome Measures
Metformin uptake in the failing myocardium
Cardiac uptake is evaluated through analysis of acquired PET-images.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03122769
Brief Title
Cardiac Uptake of Metformin, Visualized by Positron Emission Tomography
Official Title
Cardiac Uptake of Metformin and Expression of Metformin Membrane Transporter Proteins in the Human Failing Myocardium
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
April 10, 2018 (Actual)
Study Completion Date
April 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Henrik Wiggers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic
Keywords
Metformin, Heart Failure, Organic cation transporter, Pharmacogenetics, Pharmacokinetics, Positron Emission Tomography
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
All 6 subjects allocated to the study will receive 11C-metformin intravenously.
Masking
None (Open Label)
Masking Description
Open label
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
11C-metformin
Arm Type
Experimental
Arm Description
All participants allocated to the study will be included in this arm
Intervention Type
Radiation
Intervention Name(s)
11C-metformin
Intervention Description
200 MBq of 11C-metformin is injected in the cubital vein. The participant is then scanned for 120 min using Positron Emission Tomography
Primary Outcome Measure Information:
Title
Metformin uptake in the failing myocardium
Description
Cardiac uptake is evaluated through analysis of acquired PET-images.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Aarhus University Hospital, Department of Cardiology, Palle Juul-Jensens Boulevard 99
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Cardiac Uptake of Metformin, Visualized by Positron Emission Tomography
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