NCT03505788

Acetazolamide in Decompensated Heart Failure With Volume OveRload (ADVOR)

A Multi-center, Randomized, Double-blind, Phase IV Clinical Trial on the Diuretic Effects of Acetazolamide in Patients With Decompensated Heart Failure and Volume OveRload

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 519 (actual)
• Sponsor: Ziekenhuis Oost-Limburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Acute Decompensated Heart Failure
• Volume Overload

Interventions

Type	Name	Description
DRUG	Acetazolamide	In the experimental group, the patient will receive the standard of care loop diuretics and acetazolamide
DRUG	Placebo	In the placebo group, the patient will receive the standard of care loop diuretics and the placebo

Timeline

• Start date: 2018-11-11
• Primary completion: 2022-01-20
• Completion: 2022-05-16
• First posted: 2018-04-23
• Last updated: 2024-10-28
• Results posted: 2024-10-28

Locations

1 site across 1 country: Belgium