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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03720288
Other study ID # PSInCor-Acetazolamide
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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