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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
519
In the experimental group, the patient will receive the standard of care loop diuretics and acetazolamide
In the placebo group, the patient will receive the standard of care loop diuretics and the placebo
Ziekenhuis Oost-Limburg AV
Genk, Limburg, Belgium
Successful Decongestion
defined as the absence of signs of volume overload, within 3 days after randomization and with no indication for escalation of decongestive therapy.
Time frame: 4 days
Mortality
All-cause mortality during the first 3 months after start of the study
Time frame: 3 months
Hospital Readmission
If a patient is readmitted to the hospital within 3 months, this data will be collected
Time frame: 3 months
Length of Index Hospital Admission
The time frame between hospital admission and discharge will be calculated
Time frame: 3 months
EuroQoL Five Dimensions Questionnaire (EQ-5D)
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. The EQ-5D-5L health status, defined by the EQ-5D-5L descriptive system, are converted into a single index value (utility data). Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead.
Time frame: at baseline, day 4 (or discharge), at 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.