Title

Protocol of Diuretics Use in Congestive Therapy in Heart Failure
Evaluation of an Optimization Protocol for Diuretics in the Decompensation of Chronic Heart Failure: Randomized Trial in Clusters With Sequential Permutation
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Status

    Unknown status
  • Study Participants

    300
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.
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.
Study Started
May 17
2019
Primary Completion
Dec 31
2021
Anticipated
Study Completion
Dec 31
2021
Anticipated
Last Update
Apr 15
2021

Drug Furosemide

Protocol for the use of diuretics

Drug Hydrochlorothiazide

Protocol for the use of diuretics

Standard Active Comparator

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

Protocol Experimental

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

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)
No Results Posted