Phase 4
Completed N=519
Acetazolamide in Decompensated Heart Failure With Volume OveRload (ADVOR)
Acute Decompensated Heart Failure · Volume Overload
Source: ClinicalTrials.gov NCT03505788 ↗
Enrolled (actual)
519
Serious AEs
48.0%
Results posted
Oct 2024
Primary outcomePrimary: Successful Decongestion — 79; 108 Participants
◆ Published Evidence
Highly cited
557citations · ~139 / year
Acetazolamide in Acute Decompensated Heart Failure with Volume Overload.
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.
Linked Publications (5)
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Acetazolamide in Acute Decompensated Heart Failure with Volume Overload.
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Renal function and decongestion with acetazolamide in acute decompensated heart failure: the ADVOR trial.
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Natriuretic Response to Acetazolamide in Patients With Acute Heart Failure and Volume Overload.
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Decongestion With Acetazolamide in Acute Decompensated Heart Failure Across the Spectrum of Left Ventricular Ejection Fraction: A Prespecified Analysis From the ADVOR Trial.
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Serum Chloride and the Response to Acetazolamide in Patients With Acute Heart Failure and Volume Overload: A Post Hoc Analysis From the ADVOR Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Decongestion |
79; 108 | — |
| SECONDARY Mortality |
31; 39 | — |
| SECONDARY Hospital Readmission |
45; 47 | — |
| SECONDARY Length of Index Hospital Admission |
9.9; 8.8 | — |
| SECONDARY EuroQoL Five Dimensions Questionnaire (EQ-5D) |
0.571; 0.546; 0.688; 0.656; 0.592; 0.546 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03505788) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.