Cardiac Uptake of Metformin, Visualized by Positron Emission Tomography

Heart Failure, Systolic Clinical Trial

Official title:

Cardiac Uptake of Metformin and Expression of Metformin Membrane Transporter Proteins in the Human Failing Myocardium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122769
• Other study ID #: 2016-003453-15
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2017
• Last updated: April 19, 2018
• Start date: December 1, 2017
• Est. completion date: April 10, 2018

Study information

• Verified date: April 2018
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 10, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

Radiation:
• 11C-metformin
200 MBq of 11C-metformin is injected in the cubital vein. The participant is then scanned for 120 min using Positron Emission Tomography

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Cardiology, Palle Juul-Jensens Boulevard 99	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
Henrik Wiggers

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metformin uptake in the failing myocardium	Cardiac uptake is evaluated through analysis of acquired PET-images.	12 months