Acetazolamide in Patients With Acute Heart Failure (ACETA)

University of Sao Paulo General Hospital

Status and phase: Unknown; Phase 3

Conditions: Acute Heart Failure; Heart Failure

Treatments: Drug: Acetazolamide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03720288

PSInCor-Acetazolamide

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

Acetazolamide

Experimental group

Description:

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.

Treatment:

Drug: Acetazolamide

Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo