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Based on ADVOR trial, the potential of adding acetazolamide in increasing the success of decongestion, the amount of natriuresis and diuresis. However, the use of intravenous acetazolamide may not be possible in Indonesia, where the intravenous formulation is not available. This clinical research study is being conducted in single hospitals in Indonesia. We aim to learn if Oral Acetazolamide in addition to Furosemide intravenous works to treat congestion in Acute Decompensated Heart Failure, besides evaluating the total urinary output, change of NT pro BNP level, and safety profile of oral Acetazolamide.
The hypothesis of this study is oral acetazolamide works well to achieve successful decongestion.
This is a randomized, double blind study with 2 treatment groups. Participants diagnosed with ADHF who meet the inclusion criteria and no exclusion criteria are given an explanation regarding the research and additional therapy that will be given, then informed consent is requested. Participants will be randomized to one of the two treatment groups by chance. Patients randomized to the first group will receive intravenous furosemide and oral acetazolamide. Patients randomized to the other treatment group will receive a combination of iv furosemide and placebo. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Oral Acetazolamide) | Experimental | Participants who received intravenous furosemide plus acetazolamide 250 mg / 12 hours orally for up to 3 days. |
|
| Group B (Placebo) | Placebo Comparator | Participants who received intravenous furosemide plus Placebo / 12 hours orally for up to 3 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Acetazolamide | Drug | Participants will be randomized into group receiving either oral acetazolamide or placebo for up to 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Decongestion | Conditions without volume overload, no signs of excess volume within 3 days of treatment. Congestion was assessed using the volume assessment score (also called congestion score) from the ADVOR trial. The absence of fluid volume excess was defined as no more than mild edema, no residual pleural effusion, and no residual ascites. Total score ≤1 indicates that decongestion has been achieved, score >1 is considered to indicate persistent fluid volume excess (decongestion not achieved). | within 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| NT pro BNP | the effect of adding combination oral acetazolamide on NT pro BNP levels in ADHF participants who received iv furosemide | within 3 days |
| Renal Function | Kidney function is measured based on estimated GFR (eGFR) according to the CKD-EPI formula which is shown in units of mL/min/1.73 m2 taken on day 0, day 2, and day 4, every 48 hours during hospitalization (after receiving treatment). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inne P Farissa, MD | Contact | 024-8413476 | 6282 | innefarissa@gmail.com |
| Tahari B Prakoso, MD | Contact | 024-8413476 | 6282 | ibas_tbargasp@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ilham Uddin, MD | Department Cardiology and Vascular Medicine Universitas Diponegoro Kariadi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology and Vascular Medicine, Universitas Diponegoro, Kariadi Central General Hospital | Recruiting | Semarang | Central Java | 50244 | Indonesia |
Currently, the decision regarding which Individual Participant Data (IPD) will be included for sharing is still under consideration. This undecided status is due to several key factors that require thorough evaluation
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| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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This research is an experimental clinical study with a double blinded randomized controlled trial design. The study group consisted of patients with acute decompensated heart failure with volume overload who required intravenous diuretic therapy. The first group was patients who received intravenous furosemide plus acetazolamide 250 mg / 12 hours orally for up to 3 days (group A). Meanwhile, the second group was patients who received intravenous furosemide plus placebo for up to 3 days (group B).
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| Placebo | Drug | Participants will be randomized into group receiving either oral acetazolamide or placebo for up to 3 days |
|
| From date of randomization until the date of first documented worsening renal function (increased of creatinine serum level >50% of baseline creatinine) or date of death from any cause, evaluation every 48 hours or whichever came first, up to 90 days |
| Urinary Output | the amount of urine for 24 hours is measured from the time the patient arrives at the emergency room, a urinary catheter tube is installed, measured every 24 hours during hospital treatment. | From date of randomization until participants discharge from hospital up to 7 days post discharge. |
| Length of Stay | Defined as the duration of the patient receiving treatment in hospital from the time admitted to the ER until the patient was discharged/discharged from the hospital, obtained as the date of discharge from the hospital minus the sampling date +1. | From date of randomization until the date of first documented progression and discharge from hospital or date of death from any cause, whichever came first, assessed up to 30 days. |
| Kariadi Central General Hospital | Recruiting | Semarang | Central Java | 50244 | Indonesia |
|
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |