Acetazolamide in Patients With Acute Heart Failure

Phase 3

• Conditions: Heart Failure; Acute Heart Failure
• Interventions: Drug: Placebo; Drug: Acetazolamide

• Registration Number: NCT03720288
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-01
• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-25
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-30
• Primary Completion: 2019-10-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Acetazolamide	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.

Primary Outcome Measures

Name	Time	Method
diuresis and negative water balance	72 hours	The comparison between groups for diuresis and negative water balance

Secondary Outcome Measures

Name	Time	Method
Number of cases with acetazolamide side effects	72 hours	need for suspension of acetazolamide due to side effects
Level of bicarbonate	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
Number of cases with arrhythmia	72 hours	occurrence of sustained ventricular arrhythmia
Number of cases with circulatory assistance	72 hours	need for mechanical circulatory assistance
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 vasopressor	72 hours	need for vasopressor or inotropic association
Number of cases with orotracheal intubation	72 hours	need for orotracheal intubation
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 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
Rate of systolic and diastolic blood pressure	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 troponin	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 sodium	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

Trial Locations

Locations (1)

Instituto do Coração - HMFMUSP; 🇧🇷 São Paulo, Brazil