Clinical trial NCT03892148: Protocol of Diuretics Use in Congestive Therapy in Heart Failure
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Failure
Acute Heart Failure
Chronic Heart Failure
Keywords: Heart Failure
Diuretics
Diuretic resistance
Loop diuretics
Furosemide
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: University Hospital, Grenoble
name: Hospices Civils de Lyon
name: Hôpital de la Croix-Rousse
name: CH Puy en Velay
name: CH Moulins-Yzeure
name: CH Riom
name: Infirmerie Protestante de Lyon
name: CH Issoire
name: CH Annecy Genevois
First posted: 2019-03-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in the serum creatinine level
timeFrame: at 96 hours of admission
measure: change in weight
timeFrame: at 96 hours of admission
Secondary outcomes:
measure: Time of intravenous administration of diuretics
timeFrame: at 1 month
measure: severity of acute kidney injury during hospitalisation
timeFrame: at 1 month
measure: Severe Hypokaliemia
timeFrame: at month
measure: Number of rehospitalization for heart failure or kidney failure
timeFrame: At 30 days after the date of randomisation
measure: Mortality (all cause and heart failure)
timeFrame: At 30 days after the date of randomisation
measure: Dose of diuretics
timeFrame: At 30 days after the date of randomisation
measure: Description and comparison of global cost between the two groups
timeFrame: At 30 days after the date of randomisation
measure: Estimated plasma volume change
timeFrame: At 30 days after the date of randomisation
measure: change in bodyweight
timeFrame: at 96 hours after admission of patient
measure: Blood chemistry (serum creatinine)
timeFrame: month 1
measure: Blood chemistry (glomerular filtration rate)
timeFrame: month 1
measure: Blood chemistry
timeFrame: month 1
measure: Blood chemistry (plasma volume estimated)
timeFrame: month 1
Other outcomes:
Locations:
city: Annecy
country: France
facility: Ch Annecy
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
city: Grenoble
country: France
facility: CHU de GRENOBLE
city: Issoire
country: France
facility: Ch Issoire
city: Le Puy-en-Velay
country: France
facility: CH PUY
city: Lyon
country: France
facility: Infirmerie Protestante de Lyon
city: Lyon
country: France
facility: Ch Lyon Sud
city: Moulins
country: France
facility: Ch Moulins
city: Riom
country: France
facility: CH RIOM
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Guillaume CLERFOND
role: PRINCIPAL_INVESTIGATOR
References: