Acetazolamide in Patients With Acute Heart Failure

Heart Failure Clinical Trial

— ACETA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03720288
• Other study ID #: PSInCor-Acetazolamide
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2018
• Source: University of Sao Paulo General Hospital
• Contact: Alexandre Soeiro, MD
• Phone: +551126615299
• Email: alexandre.soeiro[@]bol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Drug:
• Acetazolamide
Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.
• Placebo
Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.

Locations

Country	Name	City	State
Brazil	Instituto do Coração - HMFMUSP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diuresis and negative water balance	The comparison between groups for diuresis and negative water balance	72 hours
Secondary	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)	72 hours
Secondary	Number of cases with lowering of consciousness level	lowering of consciousness level	72 hours
Secondary	Number of cases with circulatory assistance	need for mechanical circulatory assistance	72 hours
Secondary	Number of cases with vasopressor	need for vasopressor or inotropic association	72 hours
Secondary	Number of cases with orotracheal intubation	need for orotracheal intubation	72 hours
Secondary	Number of cases with arrhythmia	occurrence of sustained ventricular arrhythmia	72 hours
Secondary	Number of cases with acetazolamide side effects	need for suspension of acetazolamide due to side effects	72 hours
Secondary	Number of cases of death	ocurrence of death	72 hours
Secondary	Level of Base excess	Comparison of all hemodynamic / metabolic parameters to be evaluated (base excess)	30 days
Secondary	Level of bicarbonate	Comparison of all hemodynamic / metabolic parameters to be evaluated	30 days
Secondary	Rate of systolic and diastolic blood pressure	Comparison of all hemodynamic / metabolic parameters to be evaluated	30 days
Secondary	Level of cardiac output	Comparison of all hemodynamic / metabolic parameters to be evaluated	30 days
Secondary	Level of systolic volume	Comparison of all hemodynamic / metabolic parameters to be evaluated	30 days
Secondary	Level of arterial lactate	Comparison of all hemodynamic / metabolic parameters to be evaluated	30 days
Secondary	Level of BNP	Comparison of all hemodynamic / metabolic parameters to be evaluated	30 days
Secondary	Level of troponin	Comparison of all hemodynamic / metabolic parameters to be evaluated	30 days
Secondary	heart rate	Comparison of all hemodynamic / metabolic parameters to be evaluated	30 days
Secondary	Level of sodium	Comparison of all hemodynamic / metabolic parameters to be evaluated	30 days
Secondary	Level of potassium	Comparison of all hemodynamic / metabolic parameters to be evaluated	30 days
Secondary	Level of creatinine	Comparison of all hemodynamic / metabolic parameters to be evaluated	30 days
Secondary	Level of urea	Comparison of all hemodynamic / metabolic parameters to be evaluated	30 days