NCT02797340

Brief Summary

The study evaluates the pharmacokinetics of metformin in heart failure patients in acute and chronic state in relation to metformin transporter genotypes. Participants have heart failure and type 2 diabetes treated with metformin. Hypothesis: Primary: The renal clearance of metformin is decreased in acute state of congestive heart failure compared with chronic state. Secondary: Metformin trough values in HF patients are influenced by polymorphisms in transporter genes relevant to the pharmacokinetics of metformin.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 11, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

2.3 years

First QC Date

June 8, 2016

Last Update Submit

April 19, 2018

Conditions

Heart Failure, Systolic

Outcome Measures

Primary Outcomes (2)

  • Changes in renal clearance of metformin between patients with acute and chronic heart failure.

    approximately 2 weeks

  • Mean trough steady-state concentrations of metformin with emphasis on the intra-interindividual variability in HF patients

    3 weeks

Study Arms (1)

Interventional

EXPERIMENTAL

All participants

Other: Blood draws and urine samples for metformin concentration measurementsDrug: Metformin

Interventions

Blood draws and urine samples for metformin concentration measurementsOTHER
Interventional
MetforminDRUG
Interventional

Eligibility Criteria

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

You may qualify if:

  • Patients with heart failure
  • NYHA-class I, II, III or IV
  • Ability to understand the written patient information and to give informed consent
  • Diabetes Type 2 (and in metformin treatment for \> 1 month)
  • Stable dosage of metformin treatment for at least 1 week prior to examination

You may not qualify if:

  • 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, Systolic

Interventions

Blood Specimen CollectionMetformin

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant, associate professor, PhD, DMSc

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 13, 2016

Study Start

January 11, 2016

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

April 20, 2018

Record last verified: 2018-04

Locations

DK(1)