Clinical trial NCT03720288: Acetazolamide in Patients With Acute Heart Failure
Official title: Prospective Analysis Between Acetazolamide vs Placebo in Patients With Acute Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Heart Failure
Acute Heart Failure
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: diuresis and negative water balance
timeFrame: 72 hours
Secondary outcomes:
measure: Number of cases with worsening of renal function
timeFrame: 72 hours
measure: Number of cases with lowering of consciousness level
timeFrame: 72 hours
measure: Number of cases with circulatory assistance
timeFrame: 72 hours
measure: Number of cases with vasopressor
timeFrame: 72 hours
measure: Number of cases with orotracheal intubation
timeFrame: 72 hours
measure: Number of cases with arrhythmia
timeFrame: 72 hours
measure: Number of cases with acetazolamide side effects
timeFrame: 72 hours
measure: Number of cases of death
timeFrame: 72 hours
measure: Level of Base excess
timeFrame: 30 days
measure: Level of bicarbonate
timeFrame: 30 days
measure: Rate of systolic and diastolic blood pressure
timeFrame: 30 days
measure: Level of cardiac output
timeFrame: 30 days
measure: Level of systolic volume
timeFrame: 30 days
measure: Level of arterial lactate
timeFrame: 30 days
measure: Level of BNP
timeFrame: 30 days
measure: Level of troponin
timeFrame: 30 days
measure: heart rate
timeFrame: 30 days
measure: Level of sodium
timeFrame: 30 days
measure: Level of potassium
timeFrame: 30 days
measure: Level of creatinine
timeFrame: 30 days
measure: Level of urea
timeFrame: 30 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração - HMFMUSP
Study officials:
affiliation: Unidade Clínica de Emergência
name: Mucio Tavares, MD
role: PRINCIPAL_INVESTIGATOR
References: