Heart FailurePhase 3ACETANCT03720288
Acetazolamide in Patients With Acute Heart Failure
A Phase 3 study testing Acetazolamide in people with Heart Failure and Acute Heart Failure, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Acute Heart Failure
- What is being tested?
- Acetazolamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2018to 1 Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women aged> 18 years.
- Patients with LVEF ≤ 40% documented on echocardiography
- BNP> 500 pg / mL
- Signed consent form.
Who cannot join
- Pregnancy
- COPD
- Hepatical cirrhosis
- Known allergy to acetazolamide
- 2nd or 3rd degree atrioventricular block.
- SBP <90 mmHg or need for vasopressor / inotropic use.
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coração - HMFMUSP
São Paulo, 05403000
Alexandre Soeiro, MD, 5511-2661-5299, alexandre.soeiro@bol.com.br
About this study
Official title: Prospective Analysis Between Acetazolamide vs Placebo in Patients With Acute Heart Failure
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.
- Conditions
- Heart Failure, Acute Heart Failure
- Being tested
- Acetazolamide, Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.
PlaceboDrug
Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide | Experimental | 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. Receives: Drug: Acetazolamide |
| Placebo | Experimental | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
diuresis and negative water balance
The comparison between groups for diuresis and negative water balance
Measured: 72 hours
Secondary outcomes (21)
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)
Measured: 72 hours
Number of cases with lowering of consciousness level
lowering of consciousness level
Measured: 72 hours
Number of cases with circulatory assistance
need for mechanical circulatory assistance
Measured: 72 hours
Number of cases with vasopressor
need for vasopressor or inotropic association
Measured: 72 hours
Number of cases with orotracheal intubation
need for orotracheal intubation
Measured: 72 hours
Number of cases with arrhythmia
occurrence of sustained ventricular arrhythmia
Measured: 72 hours
Number of cases with acetazolamide side effects
need for suspension of acetazolamide due to side effects
Measured: 72 hours
Number of cases of death
ocurrence of death
Measured: 72 hours
Level of Base excess
Comparison of all hemodynamic / metabolic parameters to be evaluated (base excess)
Measured: 30 days
Level of bicarbonate
Comparison of all hemodynamic / metabolic parameters to be evaluated
Measured: 30 days
Rate of systolic and diastolic blood pressure
Comparison of all hemodynamic / metabolic parameters to be evaluated
Measured: 30 days
Level of cardiac output
Comparison of all hemodynamic / metabolic parameters to be evaluated
Measured: 30 days
Level of systolic volume
Comparison of all hemodynamic / metabolic parameters to be evaluated
Measured: 30 days
Level of arterial lactate
Comparison of all hemodynamic / metabolic parameters to be evaluated
Measured: 30 days
Level of BNP
Comparison of all hemodynamic / metabolic parameters to be evaluated
Measured: 30 days
Level of troponin
Comparison of all hemodynamic / metabolic parameters to be evaluated
Measured: 30 days
heart rate
Comparison of all hemodynamic / metabolic parameters to be evaluated
Measured: 30 days
Level of sodium
Comparison of all hemodynamic / metabolic parameters to be evaluated
Measured: 30 days
Level of potassium
Comparison of all hemodynamic / metabolic parameters to be evaluated
Measured: 30 days
Level of creatinine
Comparison of all hemodynamic / metabolic parameters to be evaluated
Measured: 30 days
Level of urea
Comparison of all hemodynamic / metabolic parameters to be evaluated
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Oct 2018
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mucio Tavares, MD, Principal investigator, Unidade Clínica de Emergência
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720288
- Sponsor's protocol ID
- PSInCor-Acetazolamide
- Acronym
- ACETA
- Status last verified
- Oct 2018
- First submitted
- 19 Oct 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis Between Acetazolamide vs Placebo in Patients With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT03720288
- Acronym / sponsor ID
- ACETA / PSInCor-Acetazolamide
- Conditions
- Heart Failure, Acute Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide | Experimental | Drug: AcetazolamideAll 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. |
| Placebo | Experimental | Drug: PlaceboAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult men and women aged> 18 years.
- Patients with LVEF ≤ 40% documented on echocardiography
- BNP> 500 pg / mL
- Signed consent form.
Key exclusion criteria (21 listed)
- Pregnancy
- COPD
- Hepatical cirrhosis
- Known allergy to acetazolamide
- 2nd or 3rd degree atrioventricular block.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetazolamidePatient will follow the treatment according to inclusion sequence, receiving the corresponding number medication. | Drug | Acetazolamide |
| PlaceboPatient will follow the treatment according to inclusion sequence, receiving the corresponding number medication. | Drug | Placebo |
Primary outcome
diuresis and negative water balance
Time frame: 72 hours
The comparison between groups for diuresis and negative water balance
21 secondary outcomes
Number of cases with worsening of renal function
Time frame: 72 hours
Number of cases with lowering of consciousness level
Time frame: 72 hours
Number of cases with circulatory assistance
Time frame: 72 hours
Number of cases with vasopressor
Time frame: 72 hours
Number of cases with orotracheal intubation
Time frame: 72 hours
Number of cases with arrhythmia
Time frame: 72 hours
Number of cases with acetazolamide side effects
Time frame: 72 hours
Number of cases of death
Time frame: 72 hours
Level of Base excess
Time frame: 30 days
Level of bicarbonate
Time frame: 30 days
Rate of systolic and diastolic blood pressure
Time frame: 30 days
Level of cardiac output
Time frame: 30 days
Level of systolic volume
Time frame: 30 days
Level of arterial lactate
Time frame: 30 days
Level of BNP
Time frame: 30 days
Level of troponin
Time frame: 30 days
heart rate
Time frame: 30 days
Level of sodium
Time frame: 30 days
Level of potassium
Time frame: 30 days
Level of creatinine
Time frame: 30 days
Level of urea
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mucio Tavares, MD principal investigator
Unidade Clínica de Emergência
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetazolamide in people with Heart Failure and Acute Heart Failure, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Soeiro, MD (+551126615299, alexandre.soeiro@bol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diuresis and negative water balance (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.