NCT02872168

Brief Summary

Recent in-vitro and in-vivo studies performed by one of the investigators (ESO, ICMPE, UPEC, France) have recently allowed to synthetize a new and easy-to-synthesized chemical compound of the furosemide (pyridinium furosemide) during furosemide degradation by electro-Fenton or bioconversion. The biological properties of pyridinium furosemide are currently under investigation. Furosemide is a diuretics currently used in the treatment of patients with heart failure. The goal of the investigators is to assay pyridinium furosemide in urine of patients treated by furosemide to demonstrate that pyridinium is or not a metabolite of furosemide in humans. This study will contribute to assess the fate of pharmaceutical residues of furosemide in the environment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

8 months

First QC Date

August 16, 2016

Last Update Submit

August 18, 2016

Conditions

Treatment by Furosemide

Outcome Measures

Primary Outcomes (1)

  • Assay of furosemide and pyridinium furosemide in urine of heart failure patients treated by furosemide

    Assay of furosemide and pyridinium furosemide in urine of heart failure patients treated by furosemide

    1 day

Interventions

Not interventionOTHER

None. there is no modification in the treatment of patients. A urine collection is carry out in patients during the day of their enrolment.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart failure patients treated by furosemide

You may qualify if:

  • Age ≥ 18 years
  • Written informed consent
  • Affiliation to social security
  • Known heart failure
  • Treatment by furosemide

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine sample

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 19, 2016

Study Start

June 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

August 19, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share