ACETA: Acetazolamide in Patients With Acute Heart Failure

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03720288

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Acute Heart Failure	Drug: Acetazolamide Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Prospective Analysis Between Acetazolamide vs Placebo in Patients With Acute Heart Failure

Actual Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Acetazolamide Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.
Experimental: 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.	Drug: Placebo Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Acetazolamide

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

Experimental: 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.

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

diuresis and negative water balance [72 hours]
The comparison between groups for diuresis and negative water balance

Secondary Outcome Measures

Number of cases with worsening of renal function [72 hours]
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 [72 hours]
lowering of consciousness level
Number of cases with circulatory assistance [72 hours]
need for mechanical circulatory assistance
Number of cases with vasopressor [72 hours]
need for vasopressor or inotropic association
Number of cases with orotracheal intubation [72 hours]
need for orotracheal intubation
Number of cases with arrhythmia [72 hours]
occurrence of sustained ventricular arrhythmia
Number of cases with acetazolamide side effects [72 hours]
need for suspension of acetazolamide due to side effects
Number of cases of death [72 hours]
ocurrence of death
Level of Base excess [30 days]
Comparison of all hemodynamic / metabolic parameters to be evaluated (base excess)
Level of bicarbonate [30 days]
Comparison of all hemodynamic / metabolic parameters to be evaluated
Rate of systolic and diastolic blood pressure [30 days]
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of cardiac output [30 days]
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of systolic volume [30 days]
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of arterial lactate [30 days]
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of BNP [30 days]
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of troponin [30 days]
Comparison of all hemodynamic / metabolic parameters to be evaluated
heart rate [30 days]
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of sodium [30 days]
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of potassium [30 days]
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of creatinine [30 days]
Comparison of all hemodynamic / metabolic parameters to be evaluated
Level of urea [30 days]
Comparison of all hemodynamic / metabolic parameters to be evaluated

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto do Coração - HMFMUSP	São Paulo		Brazil	05403000

Sponsors and Collaborators

University of Sao Paulo General Hospital

Investigators

Principal Investigator: Mucio Tavares, MD, Unidade Clínica de Emergência

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Sao Paulo General Hospital

ClinicalTrials.gov Identifier:

NCT03720288

Other Study ID Numbers:

PSInCor-Acetazolamide

First Posted:

Oct 25, 2018

Last Update Posted:

Oct 30, 2018

Last Verified:

Oct 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Failure

Acetazolamide

Study Results

No Results Posted as of Oct 30, 2018