Protocol of Diuretics Use in Congestive Therapy in Heart Failure

NCT ID: NCT03892148

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 299 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-17
• Study Completion Date: 2023-01-16

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.

Conditions

Heart Failure; Acute Heart Failure; Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Standard

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

Group Type: ACTIVE_COMPARATOR

Furosemide

Intervention Type: DRUG

Protocol for the use of diuretics

Hydrochlorothiazide

Intervention Type: DRUG

Protocol for the use of diuretics

Protocol

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

Group Type: EXPERIMENTAL

Furosemide

Intervention Type: DRUG

Protocol for the use of diuretics

Hydrochlorothiazide

Intervention Type: DRUG

Protocol for the use of diuretics

Interventions

Furosemide

Protocol for the use of diuretics

Intervention Type: DRUG

Hydrochlorothiazide

Protocol for the use of diuretics

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: collaborator

Hôpital de la Croix-Rousse

OTHER

Sponsor Role: collaborator

CH Puy en Velay

UNKNOWN

Sponsor Role: collaborator

CH Moulins-Yzeure

UNKNOWN

Sponsor Role: collaborator

CH Riom

UNKNOWN

Sponsor Role: collaborator

Infirmerie Protestante de Lyon

OTHER

Sponsor Role: collaborator

CH Issoire

UNKNOWN

Sponsor Role: collaborator

CH Annecy Genevois

OTHER

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume CLERFOND

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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

Infirmerie Protestante de Lyon

Lyon, , France

Ch Lyon Sud

Lyon, , France

Ch Moulins

Moulins, , France

CH RIOM

Riom, , France

Countries

France

Other Identifiers

2018-A02971-54

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-428

Identifier Type: -

Identifier Source: org_study_id