Protocol of Diuretics Use in Congestive Therapy in Heart Failure (ProDUCT-HF)

January 27, 2026 updated by: University Hospital, Clermont-Ferrand

Evaluation of an Optimization Protocol for Diuretics in the Decompensation of Chronic Heart Failure: Randomized Trial in Clusters With Sequential Permutation

The main objective of the study is to determine if a diuretic adaptation protocol in the decompensation of chronic heart failure is more effective but also safer than the current non-protocolized practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Diuretics are the main treatment for congestive decompensation of chronic heart failure. For symptomatic purposes, the goal is to decrease the volume overload. In these patients, loop diuretics are used in high doses, sometimes in combination with other classes of diuretics such as thiazides to achieve synergistic, faster and more effective action, and to combat diuretic's resistance. This use, well known to cardiologists and based on a rich pharmacology, more than 40 years old, lacks robust scientific data in real life. Current studies are mainly based on patients with renal insufficiency or limited to cardio-renal syndrome. The CARRESS-H study in 2012 is one of them. The protocol for the use of diuretics from this study was included in 2017 as a benchmark in a publication of the NEJM. It therefore seems necessary to consider the exercise of this protocol in the management of the decompensation of chronic cardiac heart failure. There is, to the investigator's knowledge, no similar study to test this protocol as a "real life" exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
299

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annecy, France
        • CH Annecy
      • Clermont-Ferrand, France, 63003
        • CHU clermont-ferrand
      • Grenoble, France
        • CHU de GRENOBLE
      • Issoire, France
        • Ch Issoire
      • Le Puy-en-Velay, France
        • CH PUY
      • Lyon, France
        • CH Lyon sud
      • Lyon, France, 69300
        • Infirmerie Protestante de Lyon
      • Moulins, France
        • Ch Moulins
      • Riom, France
        • CH RIOM

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients hospitalized for chronic decompensated congestive heart failure without acute pulmonary edema and acute cardiac decompensation against a background of hypertensive crisis
  • covered under a social security program
  • with legal capacity to give voluntary informed consent to participate in the study

Exclusion Criteria:

  • First episode of decompensated congestive heart failure
  • Protocolized shock or hypotension (<90 mmHg blood pressure) managed or requiring nitrovasodilators or non-invasive ventilation
  • One of the following cardiovascular pathologies: acute myocardial infarction / cardiac tamponade / aortic dissection / acute pulmonary embolism / heart transplant / ventricular assist device / acute pulmonary edema / hypertensive crisis
  • More than 12h of intravenous diuretics administered prior to inclusion
  • Generalized edema caused by cirrhosis or nephrotic syndrome
  • Requiring pleural or peritoneal tap for therapeutic purposes
  • Patient allergic or intolerant to furosemide and on long-term bumetanide use
  • Patient in dialysis or end-stage chronic kidney disease (CKD-EPI-calculated GFR <15 mL/min/1.73m²) or acute kidney injury of known non-cardiac cause
  • Severe hypokalemia (< 3 mmol/L) on admission
  • Patient who is pregnant, breastfeeding, or of childbearing age not on effective contraception
  • Adult patient safeguarded under court protection measures (guardianship, wardship, or judicial protection)

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard
Use of loop diuretics and thiazide diuretics leaves to the discretion of the responsible physician
Drug: Furosemide
Protocol for the use of diuretics
Drug: Hydrochlorothiazide
Protocol for the use of diuretics
Experimental: Protocol
use of loop diuretics and thiazide diuretics according to the CARRESS-HF protocol developed by the Heart Failure Network
Drug: Furosemide
Protocol for the use of diuretics
Drug: Hydrochlorothiazide
Protocol for the use of diuretics

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the serum creatinine level
Time Frame: at 96 hours of admission
serum creatinine
at 96 hours of admission
change in weight
Time Frame: at 96 hours of admission
The weight will be measured in kilograms
at 96 hours of admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time of intravenous administration of diuretics
Time Frame: at 1 month
Length of time of intravenous administration of diuretics in days
at 1 month
severity of acute kidney injury during hospitalisation
Time Frame: at 1 month
Acute kidney injury requiring interruption of treatment
at 1 month
Severe Hypokaliemia
Time Frame: at month
Severe hypokalaemia means hypokalaemia that requiring interruption of treatment, dialysis or transfer in intensive care.
at month
Number of rehospitalization for heart failure or kidney failure
Time Frame: At 30 days after the date of randomisation
Number of rehospitalization for heart failure or kidney failure
At 30 days after the date of randomisation
Mortality (all cause and heart failure)
Time Frame: At 30 days after the date of randomisation
Number of death of participants
At 30 days after the date of randomisation
Dose of diuretics
Time Frame: At 30 days after the date of randomisation
Comparison of diuretics dose of Furosemide and/or Thiazid diuretic. The dose will be measured on milligrams per day.
At 30 days after the date of randomisation
Description and comparison of global cost between the two groups
Time Frame: At 30 days after the date of randomisation
Description and comparison of global cost between the two groups
At 30 days after the date of randomisation
Estimated plasma volume change
Time Frame: At 30 days after the date of randomisation
Estimated plasma volume change captured via hemoglobin-to-hematocrit ratio (Hb/Ht) using the Strauss formula
At 30 days after the date of randomisation
change in bodyweight
Time Frame: at 96 hours after admission of patient
The weight will be measured in kilograms
at 96 hours after admission of patient
Blood chemistry (serum creatinine)
Time Frame: month 1
serum creatinine
month 1
Blood chemistry (glomerular filtration rate)
Time Frame: month 1
glomerular filtration rate (GFR) estimated using the CKD-EPI equation
month 1
Blood chemistry
Time Frame: month 1
NT-proBNP or BNP (as available)
month 1
Blood chemistry (plasma volume estimated)
Time Frame: month 1
plasma volume estimated via hemoglobin-to-hematocrit ratio (Hb/Ht)
month 1

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospices Civils de Lyon
University Hospital, Grenoble
Hôpital de la Croix-Rousse
CH Annecy Genevois
CH Puy en Velay
CH Moulins-Yzeure
CH Riom
Infirmerie Protestante de Lyon
CH Issoire

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guillaume CLERFOND, University Hospital, Clermont-Ferrand

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHU-428
  • 2018-A02971-54 (Other Identifier: 2018-A02971-54)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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