Acetazolamide in Patients With Acute Heart Failure

NCT ID: NCT03720288

Last Updated: 2018-10-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2020-10-01

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.

Conditions

Heart Failure; Acute Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Acetazolamide

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.

Group Type: EXPERIMENTAL

Acetazolamide

Intervention Type: DRUG

Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.

Placebo

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.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.

Interventions

Acetazolamide

Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.

Intervention Type: DRUG

Placebo

Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mucio Tavares, MD

Role: PRINCIPAL_INVESTIGATOR

Unidade Clínica de Emergência

Locations

Instituto do Coração - HMFMUSP

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Alexandre Soeiro, MD

Role: CONTACT

alexandre.soeiro@bol.com.br

+551126615299

Facility Contacts

Alexandre Soeiro, MD

Role: primary

alexandre.soeiro@bol.com.br

5511-2661-5299

Other Identifiers

PSInCor-Acetazolamide

Identifier Type: -

Identifier Source: org_study_id