KCE-17001: Multizentrische, randomisierte, doppelblinde klinische Studie der Phase IV zur diuretischen Wirkung von Acetazolamid (Diamox ®) bei Patienten mit dekompensierter Herzinsuffizienz und Volumenüberlastung - ADVOR

Trial Description
Title

 A multi-center, randomized, double-blind, phase IV clinical trial on the diuretic effects of Acetazolamide (Diamox ®) in patients with Decompensated heart failure and Volume OveRload (ADVOR) (KCE-17001)

Participants (P)

Patients with decompensated heart failure and volume overload admitted to hospital

Intervention (I)

Acetazolamide combination therapy with high-dose loop diuretics

Control (C)

Placebo combination therapy with high-dose loop diuretics

Outcome (O)

Treatment success (decongestion achieved) on the morning of day 4 without the need for escalating diuretic strategy (doubling loop diuretic dose, addition of chlorthalidone, or ultrafiltration) on the morning of day 3

Trial Design

Prospective, multi-center, randomised double blind placebo controlled phase IV clinical trial

Sample Size

519 patients

Trial duration

28 Months

Budget

€ 2 600 000 (incl. VAT)

Status

Open to recruitment

 

 

Trial team

Sponsor

Ziekenhuis Oost Limburg Autonome Verzorgingsinstelling

Chief Investigator

Wilfried Mullens MD, PhD

Trial coordinator

Katrien Tartaglia

Clinical Trial Unit, Ziekenhuis Oost-Limburg, Autonome Verzorgingsinstelling

Participating centres

24 hospitals from Flanders, Wallonia and Brussels including both University and regional hospitals

Dokumente
Protocol Published
Report Q2 2022
Publication Q2 2022
Referenzen

ClinicalTrials.gov:  NCT03505788

EudraCT:  2018-001345-14

ADVOR Webpage

 

 

FINANZIERUNGSSCHEMA

Investigator-led workstream 2017