Acetazolamide in Patients With Acute Heart Failure

• Status: Unknown status
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Treatments: Acetazolamide; Hydrochlorothiazide

Criteria

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.