Acetazolamide in Decompensated Heart Failure With Volume OveRload (ADVOR)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

519 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-11

Study Completion Date

2022-05-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Acetazolamide and Spironolactone to Increase Natriuresis in Congestive Heart Failure

NCT01973335

Heart Failure

COMPLETED PHASE4

Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload

NCT06414759

Acute Decompensated Heart Failure Volume Overload Edema

RECRUITING PHASE4

Diagnosing and Targeting Mechanisms of Diuretic Resistance in Heart Failure

NCT02546583

Heart Failure

COMPLETED PHASE1

Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment

NCT05411991

Acute Heart Failure Diuretics Drug Reactions

COMPLETED PHASE4

Preparatory Work for a Trial of Adjuncts to Diuretic Treatment in Patients Hospitalised With Heart Failure: Addressing Uncertainties and Building Consensus

NCT07281040

Heart Failure

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized, double blind study with 2 treatment groups. This means that the patients will be randomized to one of the two treatment groups by chance. Patients randomized to the first group will receive standard treatment with high doses of intravenous loop diuretics and a placebo. Patients randomized to the other treatment group will receive a combination of the same doses of loop diuretics and an additional diuretic, acetazolamide (Diamox®). All diuretics will be administered intravenously. It is expected that the patients of the treatment group with the combination therapy will have a faster reduction of their fluid overload. In consequence the treatment duration and total dose of diuretics administered will be shorter. Acetazolamide (Diamox®) is a diuretic that acts at a different location in the kidney compared to the loop diuretics. This mutual reinforcement will probably reduce the total dose and duration of the diuretics.

The study will start during the hospitalization and will last around 3 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Decompensated Heart Failure Volume Overload

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

high-dose loop diuretics+placebo

* At the moment of randomization (day 1), oral loop diuretics are stopped and the patient receives IV loop diuretics at a dose equal to the double of his oral daily maintenance dose + 500 mg IV bolus of placebo.
* If the patient still have signs of volume overload the next mornings (day 2 and day 3), the patient will receive IV loop diuretics at a dose equal to the oral daily maintenance dose + 500 mg IV bolus of placebo. It the patient has no sign of volume overload at these time points, the study treatment will be stopped.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

In the placebo group, the patient will receive the standard of care loop diuretics and the placebo

high-dose loop diuretics+acetazolamide

* At the moment of randomization (day 1), oral loop diuretics are stopped and the patient receives IV loop diuretics at a dose equal to the double of his oral daily maintenance dose + 500 mg IV bolus of acetazolamide.
* If the patient still have signs of volume overload the next mornings (day 2 and day 3), the patient will receive IV loop diuretics at a dose equal to the oral daily maintenance dose + 500 mg IV bolus of acetazolamide. It the patient has no sign of volume overload at these time points, the study treatment will be stopped.

Group Type EXPERIMENTAL

Acetazolamide

Intervention Type DRUG

In the experimental group, the patient will receive the standard of care loop diuretics and acetazolamide

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acetazolamide

In the experimental group, the patient will receive the standard of care loop diuretics and acetazolamide

Intervention Type DRUG

Placebo

In the placebo group, the patient will receive the standard of care loop diuretics and the placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No