NCT03122769

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2018

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

April 18, 2017

Last Update Submit

April 19, 2018

Conditions

Heart Failure, Systolic

Keywords

MetforminHeart FailureOrganic cation transporterPharmacogeneticsPharmacokineticsPositron Emission Tomography

Outcome Measures

Primary Outcomes (1)

  • Metformin uptake in the failing myocardium

    Cardiac uptake is evaluated through analysis of acquired PET-images.

    12 months

Study Arms (1)

11C-metformin

EXPERIMENTAL

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

Radiation: 11C-metformin

Interventions

11C-metforminRADIATION

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

11C-metformin

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Known allergy to metformin
  • Age \< 18 years
  • Current abuse of alcohol or drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Heart Failure, SystolicHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Masking Details
Open label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All 6 subjects allocated to the study will receive 11C-metformin intravenously.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior consultant, associate professor, MD, PhD, DMSc

Study Record Dates

First Submitted

April 18, 2017

First Posted

April 21, 2017

Study Start

December 1, 2017

Primary Completion

April 10, 2018

Study Completion

April 10, 2018

Last Updated

April 20, 2018

Record last verified: 2018-04

Locations

DK(1)