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

University Hospital, Clermont-Ferrand

Status and phase: Completed; Phase 4

Conditions: Chronic Heart Failure; Acute Heart Failure; Heart Failure

Treatments: Drug: Furosemide; Drug: Hydrochlorothiazide

Study type: Interventional

Funder types: Other

Identifiers

NCT03892148

2018-A02971-54 (Other Identifier)

CHU-428

Details and patient eligibility

About

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.

Full 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.

Enrollment: 299 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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299 participants in 2 patient groups

Standard

Active Comparator group

Description:

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

Treatment:

Drug: Hydrochlorothiazide

Drug: Furosemide

Protocol

Experimental group

Description:

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

Treatment:

Drug: Hydrochlorothiazide

Drug: Furosemide