NCT03892148

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Furosemide	Protocol for the use of diuretics
DRUG	Hydrochlorothiazide	Protocol for the use of diuretics

Timeline

• Start date: 2019-05-17
• Primary completion: 2023-01-16
• Completion: 2023-01-16
• First posted: 2019-03-27
• Last updated: 2026-01-28

Locations

9 sites across 1 country: France