Acute Heart Failure, Heart Failure
Conditions
Brief summary
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.
Interventions
DRUGAcetazolamide
Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.
DRUGPlacebo
Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diuresis and negative water balance | 72 hours | The comparison between groups for diuresis and negative water balance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of bicarbonate | 30 days | Comparison of all hemodynamic / metabolic parameters to be evaluated |
| Rate of systolic and diastolic blood pressure | 30 days | Comparison of all hemodynamic / metabolic parameters to be evaluated |
| Level of cardiac output | 30 days | Comparison of all hemodynamic / metabolic parameters to be evaluated |
| Number of cases with worsening of renal function | 72 hours | worsening of renal function (increase of 0.5 mg / dl or 25% increase in relation to admission creatinine) |
| Number of cases with lowering of consciousness level | 72 hours | lowering of consciousness level |
| Number of cases with circulatory assistance | 72 hours | need for mechanical circulatory assistance |
| Number of cases with vasopressor | 72 hours | need for vasopressor or inotropic association |
| Number of cases with orotracheal intubation | 72 hours | need for orotracheal intubation |
| Number of cases with arrhythmia | 72 hours | occurrence of sustained ventricular arrhythmia |
| Number of cases with acetazolamide side effects | 72 hours | need for suspension of acetazolamide due to side effects |
| Level of Base excess | 30 days | Comparison of all hemodynamic / metabolic parameters to be evaluated (base excess) |
| Level of systolic volume | 30 days | Comparison of all hemodynamic / metabolic parameters to be evaluated |
| Level of arterial lactate | 30 days | Comparison of all hemodynamic / metabolic parameters to be evaluated |
| Level of BNP | 30 days | Comparison of all hemodynamic / metabolic parameters to be evaluated |
| Level of troponin | 30 days | Comparison of all hemodynamic / metabolic parameters to be evaluated |
| heart rate | 30 days | Comparison of all hemodynamic / metabolic parameters to be evaluated |
| Level of sodium | 30 days | Comparison of all hemodynamic / metabolic parameters to be evaluated |
| Level of potassium | 30 days | Comparison of all hemodynamic / metabolic parameters to be evaluated |
| Level of creatinine | 30 days | Comparison of all hemodynamic / metabolic parameters to be evaluated |
| Level of urea | 30 days | Comparison of all hemodynamic / metabolic parameters to be evaluated |
| Number of cases of death | 72 hours | ocurrence of death |
Countries
Brazil
Contacts
Primary ContactAlexandre Soeiro, MD
Outcome results
None listed