Identification of a New Metabolite of Furosemide in Humans (PYPARK)

August 18, 2016 updated by: Philippe Le Corvoisier, Henri Mondor University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart failure patients treated by furosemide

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Written informed consent
  3. Affiliation to social security
  4. Known heart failure
  5. Treatment by furosemide

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assay of furosemide and pyridinium furosemide in urine of heart failure patients treated by furosemide
Time Frame: 1 day
Assay of furosemide and pyridinium furosemide in urine of heart failure patients treated by furosemide
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henri Mondor University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2014-A01789-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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