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

 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

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