Acetazolamide in Patients With Acute Heart Failure

Study Overview
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Brief Summary
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Introduction: Recent studies have suggested that the use of acetazolamide may assist in the vol- ume management of patients with decompensated heart failure (HF). However, prospective and randomized comparison in patients with HF and optimized diuretic therapy has not been described. Objective: The aim of this study was to evaluate the effectiveness and safety of the use of acetazolamide versus placebo in volume control in patients with decompensated HF. Methodology: For this, a unicentric, randomized, double blind and prospective study will be performed in a comparative manner. Hospital data (test results, medical outcomes, drug dose, complications) of patients will be analyzed for safety and effectiveness. Expected results: The use of acetazolamide as an adjuvant treatment is superior to the standard strategy for volume control in patients with decompensated HF.

Official Title
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Prospective Analysis Between Acetazolamide vs Placebo in Patients With Acute Heart Failure

Conditions
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Heart Failure, Acute Heart Failure

Intervention / Treatment
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* Drug: Acetazolamide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men and women aged> 18 years. Patients with LVEF ≤ 40% documented on echocardiography BNP> 500 pg / mL Signed consent form. Exclusion Criteria: Pregnancy COPD Hepatical cirrhosis Known allergy to acetazolamide 2nd or 3rd degree atrioventricular block. SBP <90 mmHg or need for vasopressor / inotropic use. Body mass index greater than 40 kg / m2. Acute coronary syndrome. Orotracheal intubation. Presence of significant pericardial effusion. Left ventricular outflow tract obstruction. Serum creatinine> 5.0 mg / dL, creatinine clearance <10 mL / min or hemodialysis. Presence of 2 or more clinical / laboratory / radiological criteria of infection defined by: Fever Leukocyte> 12,000 / mm3 or> 10% of young forms, Disuria Productive cough Bacteremia Inflammatory / infectious skin lesions Abdominal pain with signs of peritonitis Radiological image of pneumonia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetazolamide<br>All patients will receive an initial dose of intravenous furosemide of 1mg / kg, subsequently descaled to 0.5mg / kg of 6 / 6h, associated with oral hydrochlorothiazide 25mg / day and spironolactone 25mg / day orally. When the patient is randomized to the acetazolamide group, he / she will start using the adjuvant medication as acetazolamide drug capsule at the daily dose of 250 mg / day (oral) during the first three days of treatment. | Drug: Acetazolamide<br>* Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.<br>|
| Experimental: Placebo<br>All patients will receive an initial dose of intravenous furosemide of 1mg / kg, subsequently descaled to 0.5mg / kg of 6 / 6h, associated with oral hydrochlorothiazide 25mg / day and spironolactone 25mg / day orally. When the patient is randomized to the placebo group, he / she will start using the placebo drug capsule during the first three days of treatment. | Drug: Placebo<br>* Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diuresis and negative water balance | The comparison between groups for diuresis and negative water balance | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cases with worsening of renal function | worsening of renal function (increase of 0.5 mg / dl or 25% increase in relation to admission creatinine) | 72 hours | 
| Number of cases with lowering of consciousness level | lowering of consciousness level | 72 hours | 
| Number of cases with circulatory assistance | need for mechanical circulatory assistance | 72 hours | 
| Number of cases with vasopressor | need for vasopressor or inotropic association | 72 hours | 
| Number of cases with orotracheal intubation | need for orotracheal intubation | 72 hours | 
| Number of cases with arrhythmia | occurrence of sustained ventricular arrhythmia | 72 hours | 
| Number of cases with acetazolamide side effects | need for suspension of acetazolamide due to side effects | 72 hours | 
| Number of cases of death | ocurrence of death | 72 hours | 
| Level of Base excess | Comparison of all hemodynamic / metabolic parameters to be evaluated (base excess) | 30 days | 
| Level of bicarbonate | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days | 
| Rate of systolic and diastolic blood pressure | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days | 
| Level of cardiac output | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days | 
| Level of systolic volume | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days | 
| Level of arterial lactate | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days | 
| Level of BNP | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days | 
| Level of troponin | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days | 
| heart rate | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days | 
| Level of sodium | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days | 
| Level of potassium | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days | 
| Level of creatinine | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days | 
| Level of urea | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days |