Heart FailurePhase 4ProDUCT-HFNCT03892148
Protocol of Diuretics Use in Congestive Therapy in Heart Failure
A Phase 4 study testing Furosemide and Hydrochlorothiazide in people with Heart Failure and Acute Heart Failure, run by University Hospital, Clermont-Ferrand at 9 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Acute Heart Failure, Chronic Heart Failure
- What is being tested?
- Furosemide and Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 9 sitesFrance
- Study dates
- 17 May 2019to 16 Jan 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Ch Annecy
Annecy
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
CHU de GRENOBLE
Grenoble
Ch Issoire
Issoire
CH PUY
Le Puy-en-Velay
Infirmerie Protestante de Lyon
Lyon, 69300
Ch Lyon Sud
Lyon
Ch Moulins
Moulins
CH RIOM
Riom
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure, Acute Heart Failure, Chronic Heart Failure
- Being tested
- Furosemide, Hydrochlorothiazide
- Keywords
- Heart Failure, Diuretics, Diuretic resistance, Loop diuretics, Furosemide
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
Protocol for the use of diuretics
HydrochlorothiazideDrug
Protocol for the use of diuretics
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Use of loop diuretics and thiazide diuretics leaves to the discretion of the responsible physician Receives: Drug: Furosemide; Drug: Hydrochlorothiazide |
| Protocol | Experimental | use of loop diuretics and thiazide diuretics according to the CARRESS-HF protocol developed by the Heart Failure Network Receives: Drug: Furosemide; Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the serum creatinine level
serum creatinine
Measured: at 96 hours of admission
change in weight
The weight will be measured in kilograms
Measured: at 96 hours of admission
Secondary outcomes (13)
Time of intravenous administration of diuretics
Length of time of intravenous administration of diuretics in days
Measured: at 1 month
severity of acute kidney injury during hospitalisation
Acute kidney injury requiring interruption of treatment
Measured: at 1 month
Severe Hypokaliemia
Severe hypokalaemia means hypokalaemia that requiring interruption of treatment, dialysis or transfer in intensive care.
Measured: at month
Number of rehospitalization for heart failure or kidney failure
Number of rehospitalization for heart failure or kidney failure
Measured: At 30 days after the date of randomisation
Mortality (all cause and heart failure)
Number of death of participants
Measured: At 30 days after the date of randomisation
Dose of diuretics
Comparison of diuretics dose of Furosemide and/or Thiazid diuretic. The dose will be measured on milligrams per day.
Measured: At 30 days after the date of randomisation
Description and comparison of global cost between the two groups
Description and comparison of global cost between the two groups
Measured: At 30 days after the date of randomisation
Estimated plasma volume change
Estimated plasma volume change captured via hemoglobin-to-hematocrit ratio (Hb/Ht) using the Strauss formula
Measured: At 30 days after the date of randomisation
change in bodyweight
The weight will be measured in kilograms
Measured: at 96 hours after admission of patient
Blood chemistry (serum creatinine)
serum creatinine
Measured: month 1
Blood chemistry (glomerular filtration rate)
glomerular filtration rate (GFR) estimated using the CKD-EPI equation
Measured: month 1
Blood chemistry
NT-proBNP or BNP (as available)
Measured: month 1
Blood chemistry (plasma volume estimated)
plasma volume estimated via hemoglobin-to-hematocrit ratio (Hb/Ht)
Measured: month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start17 May 2019
- Primary completion16 Jan 2023
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Grenoble, Hospices Civils de Lyon, Hôpital de la Croix-Rousse, CH Puy en Velay, CH Moulins-Yzeure, CH Riom, Infirmerie Protestante de Lyon, CH Issoire, CH Annecy Genevois
- Responsible party
- Sponsor
- Investigators
- Guillaume CLERFOND, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892148
- Sponsor's protocol ID
- CHU-428
- Other IDs
- 2018-A02971-54
- Acronym
- ProDUCT-HF
- Status last verified
- Jan 2026
- First submitted
- 22 Feb 2019
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Optimization Protocol for Diuretics in the Decompensation of Chronic Heart Failure: Randomized Trial in Clusters With Sequential Permutation
- ClinicalTrials.gov ID
- NCT03892148
- Acronym / sponsor ID
- ProDUCT-HF / CHU-428
- Conditions
- Heart Failure, Acute Heart Failure, Chronic Heart Failure
- Keywords
- Heart Failure, Diuretics, Diuretic resistance, Loop diuretics, Furosemide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- University Hospital, Grenoble, Hospices Civils de Lyon, Hôpital de la Croix-Rousse, CH Puy en Velay, CH Moulins-Yzeure, CH Riom, Infirmerie Protestante de Lyon, CH Issoire, CH Annecy Genevois
- Study start
- 17 May 2019 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Drug: Furosemide, Drug: HydrochlorothiazideUse of loop diuretics and thiazide diuretics leaves to the discretion of the responsible physician |
| Protocol | Experimental | Drug: Furosemide, Drug: Hydrochlorothiazideuse of loop diuretics and thiazide diuretics according to the CARRESS-HF protocol developed by the Heart Failure Network |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FurosemideProtocol for the use of diuretics | Drug | Protocol, Standard |
| HydrochlorothiazideProtocol for the use of diuretics | Drug | Protocol, Standard |
Primary outcome
Change in the serum creatinine level
Time frame: at 96 hours of admission
serum creatinine
change in weight
Time frame: at 96 hours of admission
The weight will be measured in kilograms
13 secondary outcomes
Time of intravenous administration of diuretics
Time frame: at 1 month
severity of acute kidney injury during hospitalisation
Time frame: at 1 month
Severe Hypokaliemia
Time frame: at month
Number of rehospitalization for heart failure or kidney failure
Time frame: At 30 days after the date of randomisation
Mortality (all cause and heart failure)
Time frame: At 30 days after the date of randomisation
Dose of diuretics
Time frame: 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
Estimated plasma volume change
Time frame: At 30 days after the date of randomisation
change in bodyweight
Time frame: at 96 hours after admission of patient
Blood chemistry (serum creatinine)
Time frame: month 1
Blood chemistry (glomerular filtration rate)
Time frame: month 1
Blood chemistry
Time frame: month 1
Blood chemistry (plasma volume estimated)
Time frame: month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume CLERFOND principal investigator
University Hospital, Clermont-Ferrand
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Furosemide and Hydrochlorothiazide in people with Heart Failure and Acute Heart Failure, run by University Hospital, Clermont-Ferrand at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the serum creatinine level (time frame: at 96 hours of admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.