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

Primary Purpose

Heart Failure, Acute Heart Failure, Chronic Heart Failure

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Furosemide
Hydrochlorothiazide
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Diuretics, Diuretic resistance, Loop diuretics, Furosemide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ch AnnecyRecruiting
  • Chu Clermont-FerrandRecruiting
  • CHU de GRENOBLERecruiting
  • Ch IssoireRecruiting
  • CH PUYRecruiting
  • Infirmerie Protestante de LyonRecruiting
  • Ch Lyon SudRecruiting
  • Ch MoulinsRecruiting
  • CH RIOMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard

Protocol

Arm Description

Use of loop diuretics and thiazide diuretics leaves to the discretion of the responsible physician

use of loop diuretics and thiazide diuretics according to the CARRESS-HF protocol developed by the Heart Failure Network

Outcomes

Primary Outcome Measures

Change in the serum creatinine level
serum creatinine
change in weight
The weight will be measured in kilograms

Secondary Outcome Measures

Time of intravenous administration of diuretics
Length of time of intravenous administration of diuretics in days
severity of acute kidney injury during hospitalisation
Acute kidney injury requiring interruption of treatment
Severe Hypokaliemia
Severe hypokalaemia means hypokalaemia that requiring interruption of treatment, dialysis or transfer in intensive care.
Number of rehospitalization for heart failure or kidney failure
Number of rehospitalization for heart failure or kidney failure
Mortality (all cause and heart failure)
Number of death of participants
Dose of diuretics
Comparison of diuretics dose of Furosemide and/or Thiazid diuretic. The dose will be measured on milligrams per day.
Description and comparison of global cost between the two groups
Description and comparison of global cost between the two groups
Estimated plasma volume change
Estimated plasma volume change captured via hemoglobin-to-hematocrit ratio (Hb/Ht) using the Strauss formula
change in bodyweight
The weight will be measured in kilograms
Blood chemistry (serum creatinine)
serum creatinine
Blood chemistry (glomerular filtration rate)
glomerular filtration rate (GFR) estimated using the CKD-EPI equation
Blood chemistry
NT-proBNP or BNP (as available)
Blood chemistry (plasma volume estimated)
plasma volume estimated via hemoglobin-to-hematocrit ratio (Hb/Ht)

Full Information

First Posted
February 22, 2019
Last Updated
April 13, 2021
Sponsor
University Hospital, Clermont-Ferrand
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
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1. Study Identification

Unique Protocol Identification Number
NCT03892148
Brief Title
Protocol of Diuretics Use in Congestive Therapy in Heart Failure
Acronym
ProDUCT-HF
Official Title
Evaluation of an Optimization Protocol for Diuretics in the Decompensation of Chronic Heart Failure: Randomized Trial in Clusters With Sequential Permutation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 17, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Acute Heart Failure, Chronic Heart Failure
Keywords
Heart Failure, Diuretics, Diuretic resistance, Loop diuretics, Furosemide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Use of loop diuretics and thiazide diuretics leaves to the discretion of the responsible physician
Arm Title
Protocol
Arm Type
Experimental
Arm Description
use of loop diuretics and thiazide diuretics according to the CARRESS-HF protocol developed by the Heart Failure Network
Intervention Type
Drug
Intervention Name(s)
Furosemide
Intervention Description
Protocol for the use of diuretics
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide
Intervention Description
Protocol for the use of diuretics
Primary Outcome Measure Information:
Title
Change in the serum creatinine level
Description
serum creatinine
Time Frame
at 96 hours of admission
Title
change in weight
Description
The weight will be measured in kilograms
Time Frame
at 96 hours of admission
Secondary Outcome Measure Information:
Title
Time of intravenous administration of diuretics
Description
Length of time of intravenous administration of diuretics in days
Time Frame
at 1 month
Title
severity of acute kidney injury during hospitalisation
Description
Acute kidney injury requiring interruption of treatment
Time Frame
at 1 month
Title
Severe Hypokaliemia
Description
Severe hypokalaemia means hypokalaemia that requiring interruption of treatment, dialysis or transfer in intensive care.
Time Frame
at month
Title
Number of rehospitalization for heart failure or kidney failure
Description
Number of rehospitalization for heart failure or kidney failure
Time Frame
At 30 days after the date of randomisation
Title
Mortality (all cause and heart failure)
Description
Number of death of participants
Time Frame
At 30 days after the date of randomisation
Title
Dose of diuretics
Description
Comparison of diuretics dose of Furosemide and/or Thiazid diuretic. The dose will be measured on milligrams per day.
Time Frame
At 30 days after the date of randomisation
Title
Description and comparison of global cost between the two groups
Description
Description and comparison of global cost between the two groups
Time Frame
At 30 days after the date of randomisation
Title
Estimated plasma volume change
Description
Estimated plasma volume change captured via hemoglobin-to-hematocrit ratio (Hb/Ht) using the Strauss formula
Time Frame
At 30 days after the date of randomisation
Title
change in bodyweight
Description
The weight will be measured in kilograms
Time Frame
at 96 hours after admission of patient
Title
Blood chemistry (serum creatinine)
Description
serum creatinine
Time Frame
month 1
Title
Blood chemistry (glomerular filtration rate)
Description
glomerular filtration rate (GFR) estimated using the CKD-EPI equation
Time Frame
month 1
Title
Blood chemistry
Description
NT-proBNP or BNP (as available)
Time Frame
month 1
Title
Blood chemistry (plasma volume estimated)
Description
plasma volume estimated via hemoglobin-to-hematocrit ratio (Hb/Ht)
Time Frame
month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
04 73 75 49 63
Email
drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume CLERFOND
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ch Annecy
City
Annecy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu CHACORNAC
Facility Name
Chu Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise LACLAUTRE
Phone
04 73 75 49 63
Email
drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Guillaume CLERFOND
First Name & Middle Initial & Last Name & Degree
Romain ESCHALIER
First Name & Middle Initial & Last Name & Degree
Pascal MOTREFF
Facility Name
CHU de GRENOBLE
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gérald VANZETTO
Facility Name
Ch Issoire
City
Issoire
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youssef NAHLI
Facility Name
CH PUY
City
Le Puy-en-Velay
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier DE TAURIAC
Facility Name
Infirmerie Protestante de Lyon
City
Lyon
ZIP/Postal Code
69300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salim MADI
Facility Name
Ch Lyon Sud
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brahim HARBAOUI
Facility Name
Ch Moulins
City
Moulins
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hassan BARAKE
Facility Name
CH RIOM
City
Riom
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence FLORK

12. IPD Sharing Statement

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Protocol of Diuretics Use in Congestive Therapy in Heart Failure

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