Cardiac Uptake of Metformin, Visualized by Positron Emission Tomography

Sponsor

Henrik Wiggers (Other)

Overall Status

Completed

CT.gov ID

NCT03122769

Collaborator

(none)

Enrollment

Location

Arm

4.3

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Systolic	Radiation: 11C-metformin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All 6 subjects allocated to the study will receive 11C-metformin intravenously.All 6 subjects allocated to the study will receive 11C-metformin intravenously.

Masking:

None (Open Label)

Masking Description:

Open label

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2017

Actual Primary Completion Date :

Apr 10, 2018

Actual Study Completion Date :

Apr 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 11C-metformin All participants allocated to the study will be included in this arm	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

Arm

Intervention/Treatment

Experimental: 11C-metformin

All participants allocated to the study will be included in this arm

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

Outcome Measures

Primary Outcome Measures

Metformin uptake in the failing myocardium [12 months]
Cardiac uptake is evaluated through analysis of acquired PET-images.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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