Acetazolamide in Patients With Acute Heart Failure

NCT03720288 | Unknown Phase 3

• 1 other identifier: PSInCor-Acetazolamide
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• diuresis and negative water balance

  The comparison between groups for diuresis and negative water balance

  72 hours

Secondary Outcomes (21)

• Number of cases with worsening of renal function

  72 hours

• Number of cases with lowering of consciousness level

  72 hours

• Number of cases with circulatory assistance

  72 hours

• Number of cases with vasopressor

  72 hours

• Number of cases with orotracheal intubation

  72 hours

Study Arms (2)

Acetazolamide

EXPERIMENTAL

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

Placebo

EXPERIMENTAL

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

Interventions

Acetazolamide DRUG

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

Acetazolamide

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult men and women aged\> 18 years.
• Patients with LVEF ≤ 40% documented on echocardiography
• BNP\> 500 pg / mL
• Signed consent form.

You may not qualify if:

• Pregnancy
• COPD
• Hepatical cirrhosis
• Known allergy to acetazolamide
• nd 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,

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração - HMFMUSP

São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mucio Tavares, MD

  Unidade Clínica de Emergência

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Soeiro, MD

CONTACT

+551126615299; alexandre.soeiro@bol.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 25, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2020
• Last Updated: October 30, 2018

Record last verified: 2018-10

Locations

BR (1)