Protocol of Diuretics Use in Congestive Therapy in Heart Failure

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03892148
• Other study ID #: CHU-428
• Secondary ID: 2018-A02971-54
• Status: Recruiting
• Phase: Phase 4
• Start date: May 17, 2019
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: 04 73 75 49 63
• Email: drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Heart Failure
• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• Furosemide
Protocol for the use of diuretics
• Hydrochlorothiazide
Protocol for the use of diuretics

Locations

Country	Name	City	State
France	Ch Annecy	Annecy
France	Chu Clermont-Ferrand	Clermont-Ferrand
France	CHU de GRENOBLE	Grenoble
France	Ch Issoire	Issoire
France	CH PUY	Le Puy-en-Velay
France	Ch Lyon Sud	Lyon
France	Infirmerie Protestante de Lyon	Lyon
France	Ch Moulins	Moulins
France	CH RIOM	Riom

Sponsors (10)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	CH Annecy Genevois, CH Issoire, CH Moulins-Yzeure, CH Puy en Velay, CH Riom, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Infirmerie Protestante de Lyon, University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the serum creatinine level	serum creatinine	at 96 hours of admission
Primary	change in weight	The weight will be measured in kilograms	at 96 hours of admission
Secondary	Time of intravenous administration of diuretics	Length of time of intravenous administration of diuretics in days	at 1 month
Secondary	severity of acute kidney injury during hospitalisation	Acute kidney injury requiring interruption of treatment	at 1 month
Secondary	Severe Hypokaliemia	Severe hypokalaemia means hypokalaemia that requiring interruption of treatment, dialysis or transfer in intensive care.	at month
Secondary	Number of rehospitalization for heart failure or kidney failure	Number of rehospitalization for heart failure or kidney failure	At 30 days after the date of randomisation
Secondary	Mortality (all cause and heart failure)	Number of death of participants	At 30 days after the date of randomisation
Secondary	Dose of diuretics	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
Secondary	Description and comparison of global cost between the two groups	Description and comparison of global cost between the two groups	At 30 days after the date of randomisation
Secondary	Estimated plasma volume change	Estimated plasma volume change captured via hemoglobin-to-hematocrit ratio (Hb/Ht) using the Strauss formula	At 30 days after the date of randomisation
Secondary	change in bodyweight	The weight will be measured in kilograms	at 96 hours after admission of patient
Secondary	Blood chemistry (serum creatinine)	serum creatinine	month 1
Secondary	Blood chemistry (glomerular filtration rate)	glomerular filtration rate (GFR) estimated using the CKD-EPI equation	month 1
Secondary	Blood chemistry	NT-proBNP or BNP (as available)	month 1
Secondary	Blood chemistry (plasma volume estimated)	plasma volume estimated via hemoglobin-to-hematocrit ratio (Hb/Ht)	month 1