Acetazolamide in Decompensated Heart Failure With Volume OveRload (ADVOR) (Advor)
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|ClinicalTrials.gov Identifier: NCT03505788|
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Decompensated Heart Failure Volume Overload||Drug: Acetazolamide Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||519 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||November 11, 2018|
|Estimated Primary Completion Date :||October 5, 2020|
|Estimated Study Completion Date :||January 1, 2021|
Placebo Comparator: high-dose loop diuretics+placebo
In the placebo group, the patient will receive the standard of care loop diuretics and the placebo
Experimental: high-dose loop diuretics+acetazolamide
In the experimental group, the patient will receive the standard of care loop diuretics and acetazolamide
- Treatment success [ Time Frame: 4 days ]Treatment success (decongestion achieved) on the morning of day 4 without the need for escalating diuretic strategy on the morning of day 3.
- Mortality [ Time Frame: 3 months ]All-cause mortality during the first 3 months after start of the study
- Hospital readmission [ Time Frame: 3 months ]If a patient is readmitted to the hospital within 3 months, this data will be collected
- Length of index hospital admission [ Time Frame: 3 months ]The time frame between hospital admission and discharge will be calculated
- EuroQoL five dimensions questionnaire (EQ-5D) [ Time Frame: at day 1, day 4, at any hospital readmission within 3 months, at 3 months ]A questionnaire about the patients' quality of life will be performed at baseline, the morning of day 4, at any readmission, 3 months. The questionnaire is divided into 5 levels of severity with a score varying from 1 to 5. 1 indicates no problems and 5 indicates severe problems.
- Body weight [ Time Frame: day 1, day 2, day3, day 4 ]Body weight change after day 1, 2, 3, 4 discharge compared to admission
- Use of medication [ Time Frame: 3 months ]A list of specific medication will be collected
- Diureses and natriuresis [ Time Frame: 3 days ]The volume of urine will be measured until the morning of day 3. In the same urine, natriuresis will be assessed.
- Adverse events [ Time Frame: 3 months ]Any undesired clinical outcomes will be reported
- Abnormal blood parameters [ Time Frame: an average of 7 days ]Any abnormal laboratory parameters in the blood (electrolytes, heart failure markers and anemia markers) during hospital admission will be reported
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505788
|Contact: Wilfried Mullens, MD PhDemail@example.com|
|Contact: Katrien Tartagliafirstname.lastname@example.org|
|Ziekenhuis Oost-Limburg AV||Recruiting|
|Genk, Limburg, Belgium, 3600|
|Contact: Wilfried Mullens, MD PhD +32 89 32 7325|
|Principal Investigator:||Wiflried Mullens, MD PhD||Ziekenhuis Oost-Limburg|