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Acetazolamide in Patients With Acute Heart Failure (ACETA)

Primary Purpose

Heart Failure, Acute Heart Failure

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Acetazolamide
Placebo
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Instituto do Coração - HMFMUSPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acetazolamide

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

diuresis and negative water balance
The comparison between groups for diuresis and negative water balance

Secondary Outcome Measures

Number of cases with worsening of renal function
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
lowering of consciousness level
Number of cases with circulatory assistance
need for mechanical circulatory assistance
Number of cases with vasopressor
need for vasopressor or inotropic association
Number of cases with orotracheal intubation
need for orotracheal intubation
Number of cases with arrhythmia
occurrence of sustained ventricular arrhythmia
Number of cases with acetazolamide side effects
need for suspension of acetazolamide due to side effects
Number of cases of death
ocurrence of death
Level of Base excess
Comparison of all hemodynamic / metabolic parameters to be evaluated (base excess)
Level of bicarbonate
Comparison of all hemodynamic / metabolic parameters to be evaluated
Rate of systolic and diastolic blood pressure
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of cardiac output
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of systolic volume
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of arterial lactate
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of BNP
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of troponin
Comparison of all hemodynamic / metabolic parameters to be evaluated
heart rate
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of sodium
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of potassium
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of creatinine
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of urea
Comparison of all hemodynamic / metabolic parameters to be evaluated

Full Information

First Posted
October 19, 2018
Last Updated
October 26, 2018
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03720288
Brief Title
Acetazolamide in Patients With Acute Heart Failure
Acronym
ACETA
Official Title
Prospective Analysis Between Acetazolamide vs Placebo in Patients With Acute Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Acute Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acetazolamide
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Intervention Description
Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.
Primary Outcome Measure Information:
Title
diuresis and negative water balance
Description
The comparison between groups for diuresis and negative water balance
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Number of cases with worsening of renal function
Description
worsening of renal function (increase of 0.5 mg / dl or 25% increase in relation to admission creatinine)
Time Frame
72 hours
Title
Number of cases with lowering of consciousness level
Description
lowering of consciousness level
Time Frame
72 hours
Title
Number of cases with circulatory assistance
Description
need for mechanical circulatory assistance
Time Frame
72 hours
Title
Number of cases with vasopressor
Description
need for vasopressor or inotropic association
Time Frame
72 hours
Title
Number of cases with orotracheal intubation
Description
need for orotracheal intubation
Time Frame
72 hours
Title
Number of cases with arrhythmia
Description
occurrence of sustained ventricular arrhythmia
Time Frame
72 hours
Title
Number of cases with acetazolamide side effects
Description
need for suspension of acetazolamide due to side effects
Time Frame
72 hours
Title
Number of cases of death
Description
ocurrence of death
Time Frame
72 hours
Title
Level of Base excess
Description
Comparison of all hemodynamic / metabolic parameters to be evaluated (base excess)
Time Frame
30 days
Title
Level of bicarbonate
Description
Comparison of all hemodynamic / metabolic parameters to be evaluated
Time Frame
30 days
Title
Rate of systolic and diastolic blood pressure
Description
Comparison of all hemodynamic / metabolic parameters to be evaluated
Time Frame
30 days
Title
Level of cardiac output
Description
Comparison of all hemodynamic / metabolic parameters to be evaluated
Time Frame
30 days
Title
Level of systolic volume
Description
Comparison of all hemodynamic / metabolic parameters to be evaluated
Time Frame
30 days
Title
Level of arterial lactate
Description
Comparison of all hemodynamic / metabolic parameters to be evaluated
Time Frame
30 days
Title
Level of BNP
Description
Comparison of all hemodynamic / metabolic parameters to be evaluated
Time Frame
30 days
Title
Level of troponin
Description
Comparison of all hemodynamic / metabolic parameters to be evaluated
Time Frame
30 days
Title
heart rate
Description
Comparison of all hemodynamic / metabolic parameters to be evaluated
Time Frame
30 days
Title
Level of sodium
Description
Comparison of all hemodynamic / metabolic parameters to be evaluated
Time Frame
30 days
Title
Level of potassium
Description
Comparison of all hemodynamic / metabolic parameters to be evaluated
Time Frame
30 days
Title
Level of creatinine
Description
Comparison of all hemodynamic / metabolic parameters to be evaluated
Time Frame
30 days
Title
Level of urea
Description
Comparison of all hemodynamic / metabolic parameters to be evaluated
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Soeiro, MD
Phone
+551126615299
Email
alexandre.soeiro@bol.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mucio Tavares, MD
Organizational Affiliation
Unidade Clínica de Emergência
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Coração - HMFMUSP
City
São Paulo
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Soeiro, MD
Phone
5511-2661-5299
Email
alexandre.soeiro@bol.com.br

12. IPD Sharing Statement

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Acetazolamide in Patients With Acute Heart Failure

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