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Trial record 1 of 1102 for:    PRODUCT HF
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Protocol of Diuretics Use in Congestive Therapy in Heart Failure (ProDUCT-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03892148
Recruitment Status : Unknown
Verified April 2021 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : March 27, 2019
Last Update Posted : April 15, 2021
Sponsor:
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
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Acute Heart Failure Chronic Heart Failure Drug: Furosemide Drug: Hydrochlorothiazide Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of an Optimization Protocol for Diuretics in the Decompensation of Chronic Heart Failure: Randomized Trial in Clusters With Sequential Permutation
Actual Study Start Date : May 17, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Change in the serum creatinine level [ Time Frame: at 96 hours of admission ]
    serum creatinine

  2. change in weight [ Time Frame: at 96 hours of admission ]
    The weight will be measured in kilograms


Secondary Outcome Measures :
  1. Time of intravenous administration of diuretics [ Time Frame: at 1 month ]
    Length of time of intravenous administration of diuretics in days

  2. severity of acute kidney injury during hospitalisation [ Time Frame: at 1 month ]
    Acute kidney injury requiring interruption of treatment

  3. Severe Hypokaliemia [ Time Frame: at month ]
    Severe hypokalaemia means hypokalaemia that requiring interruption of treatment, dialysis or transfer in intensive care.

  4. 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

  5. Mortality (all cause and heart failure) [ Time Frame: At 30 days after the date of randomisation ]
    Number of death of participants

  6. 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.

  7. 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

  8. 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

  9. change in bodyweight [ Time Frame: at 96 hours after admission of patient ]
    The weight will be measured in kilograms

  10. Blood chemistry (serum creatinine) [ Time Frame: month 1 ]
    serum creatinine

  11. Blood chemistry (glomerular filtration rate) [ Time Frame: month 1 ]
    glomerular filtration rate (GFR) estimated using the CKD-EPI equation

  12. Blood chemistry [ Time Frame: month 1 ]
    NT-proBNP or BNP (as available)

  13. Blood chemistry (plasma volume estimated) [ Time Frame: month 1 ]
    plasma volume estimated via hemoglobin-to-hematocrit ratio (Hb/Ht)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892148


Contacts
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Contact: Lise LACLAUTRE 04 73 75 49 63 drci@chu-clermontferrand.fr

Locations
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France
Ch Annecy Recruiting
Annecy, France
Sub-Investigator: Mathieu CHACORNAC         
Chu Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    04 73 75 49 63    drci@chu-clermontferrand.fr   
Principal Investigator: Guillaume CLERFOND         
Sub-Investigator: Romain ESCHALIER         
Sub-Investigator: Pascal MOTREFF         
CHU de GRENOBLE Recruiting
Grenoble, France
Sub-Investigator: Gérald VANZETTO         
Ch Issoire Recruiting
Issoire, France
Sub-Investigator: Youssef NAHLI         
CH PUY Recruiting
Le Puy-en-Velay, France
Sub-Investigator: Olivier DE TAURIAC         
Infirmerie Protestante de Lyon Recruiting
Lyon, France, 69300
Sub-Investigator: Salim MADI         
Ch Lyon Sud Recruiting
Lyon, France
Sub-Investigator: Brahim HARBAOUI         
Ch Moulins Recruiting
Moulins, France
Sub-Investigator: Hassan BARAKE         
CH RIOM Recruiting
Riom, France
Sub-Investigator: Laurence FLORK         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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
Investigators
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Principal Investigator: Guillaume CLERFOND University Hospital, Clermont-Ferrand
More Information
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03892148    
Other Study ID Numbers: CHU-428
2018-A02971-54 ( Other Identifier: 2018-A02971-54 )
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Heart Failure
Diuretics
Diuretic resistance
Loop diuretics
Furosemide
Additional relevant MeSH terms:
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Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Heart Failure
Heart Diseases
Cardiovascular Diseases
Hydrochlorothiazide
 Furosemide
Diuretics
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Potassium Chloride Symporter Inhibitors