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)

Summary (Dutch or French)

Two percent of the Belgian population has heart failure (HF), with 15.000 new cases being diagnosed annually and 3% of the annual health care budget spent on HF, of which most is related to recurrent hospitalisation for decompensated HF with a tremendous negative impact on quality of life. Therefore, strategies that reduce the number of hospital admittances / length of stay will have an immediate impact on the health care budget and patients’ quality of life.

Treatment of decompensated HF mainly focuses on symptomatic relief of signs and symptoms of congestion (‘increased filling pressures’) and edema (‘fluid retention’) through administration of diuretics (‘water pills’), although clear evidence on the optimal agent, dosing schedule, and administration route is lacking. Importantly, persistent congestion and volume overload at discharge, has been consistently associated with higher mortality and more frequent readmissions for HF. Therefore, an important therapeutic target in HF is to achieve better decongestion.

The ADVOR study is a multi-centre randomised double blind trial (neither patients nor their doctors will know which treatment they receive). It will investigate if an improved application of existing decongestive therapies, based on strong scientific reasoning, will result in a better decongestion which should lead to improved outcome for patients and society. More specifically, ADVOR will investigate if the addition of a very easy to use diuretic agent (acetazolamide) which is off-patent and available at a very low cost (less than 10€) will reduce the average length of hospital stay and rehospitalisation rate, which could be accompanied by improved quality of life and a cost saving of 2,500€ per hospitalised patient.

 

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

Documents
Protocol Download here (not yet available)
Report Expected for Q1 2021
Publication Expected for Q1 2021
References

ClinicalTrials.gov:  NCT03505788

EudraCT:  2018-001345-14

ADVOR Webpage

Protocol publication

Funding scheme

Investigator-led workstream 2017