Cardiac Uptake of Metformin, Visualized by Positron Emission Tomography

NCT ID: NCT03122769

Last Updated: 2018-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-04-10

Brief Summary

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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).

Detailed Description

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Conditions

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Heart Failure, Systolic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

Open label

Study Groups

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11C-metformin

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

Group Type EXPERIMENTAL

11C-metformin

Intervention Type RADIATION

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

Interventions

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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

Intervention Type RADIATION

Eligibility 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henrik Wiggers

OTHER

Sponsor Role lead

Responsible Party

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Henrik Wiggers

Senior consultant, associate professor, MD, PhD, DMSc

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Aarhus University Hospital, Department of Cardiology, Palle Juul-Jensens Boulevard 99

Aarhus N, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2016-003453-15

Identifier Type: -

Identifier Source: org_study_id

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