Acetazolamide in Decompensated Heart Failure With Volume OveRload (ADVOR)

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical research study is being conducted in multiple hospitals in Belgium and approximately 519 patients with acute decompensated heart failure are expected to participate. Large-scale research shows that 90% of the physicians treat volume overload with high doses of loop diuretics. However, there is not a lot of scientific data available regarding the optimal doses of these diuretic medications. In addition, it is observed that a lot of people, treated with these drugs, are being readmitted to the hospital due to a new episode of heart failure. The hypothesis of this study is that the volume overload could be better treated when patients receive a combination of different types of diuretics. Additionally, the total dose of the administrated diuretics might be lower this way.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ziekenhuis Oost-Limburg
• Treatments: Acetazolamide; Diuretics; Sodium Potassium Chloride Symporter Inhibitors

Criteria

Inclusion Criteria:

• Signed written informed consent must be obtained before any study assessment is performed

• Male or female patients 18 years of age or older

• An elective or emergency hospital admission with clinical diagnosis of decompensated HF with at least one clinical sign of volume overload (e.g. oedema (score 2 or more), ascites confirmed by echography or pleural effusion confirmed by chest X-ray or echography)

• Maintenance therapy with oral loop diuretics at a dose of at least 1 mg bumetanide or an equivalent dose for at least 1 month before hospital admission (Conversion: 1 mg bumetanide = 40 mg furosemide = 20 mg torsemide)

• Plasma NT-proBNP levels >1000 ng/mL or BNP levels >250 ng/mL at the time of screening.

• Assessed LVEF by any imaging technique; i.e. echocardiography, catheterization, nuclear scan or magnetic resonance imaging within 12 months of inclusion

Exclusion Criteria:

• Concurrent diagnosis of an acute coronary syndrome defined as typical chest pain in addition to a troponin rise above the 99th percentile and/or electrocardiographic changes suggestive of cardiac ischemia

• History of congenital heart disease requiring surgical correction

• History of a cardiac transplantation and/or ventricular assist device

• Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg at the moment of admission

• Expected use of intravenous inotropes, vasopressors or nitroprusside during the study. Use of nitrates is allowed only if the patient's systolic blood pressure is >140 mmHg

• Estimated glomerular filtration rate <20 mL/min/1.73m² at screening

• Use of renal replacement therapy or ultrafiltration at any time before study inclusion

• Treatment with acetazolamide during the index hospitalization and prior to randomization

• Exposure to nephrotoxic agents (i.e. contrast dye) anticipated within the next 3 days

• Use of any non-protocol defined diuretic agent with the exception of mineralocorticoid receptor antagonists. Thiazides, metolazone, indapamide and amiloride should be stopped upon study inclusion. If patient is taking a combination drug including a thiazide-type diuretic, the thiazide-type diuretic should be stopped

• Current use of sodium-glucose transporter-2 inhibitors

• Subjects who are pregnant or breastfeeding