Chronic Heart FailurePhase 4ORION-ANCT05802849
Acetazolamide Per os for Decompensation of Heart Failure
A Phase 4 study testing Acetazolamide in people with Chronic Heart Failure, run by Samara State Medical University at 1 site in Russia.
Trial summary
The main causes of chronic heart failure (CHF) are arterial hypertension and coronary artery disease, less often cardiomyopathy, pericarditis, metastatic myocardial lesions. It should be noted that up to 50% of patients have a preserved left ventricular ejection fraction (LVEF), while its prevalence is progressively… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Acetazolamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteRussia
- Study dates
- 1 May 2023to 1 Dec 2025
- Phase
- Phase 4
- 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
- Men or women aged 18 years and older
- Decompensated CHF NYHA II-IV, which required intravenous administration of diuretics
- Any injection fraction of left ventricle*
- Signed informed consent to participate in the study.
- in patients with LV LV ≥ 50%: the presence of structural changes of the heart# (left ventricular myocardial hypertrophy, enlargement of the left atrium) and/or diastolic dysfunction# and/or increased levels of BNP or NT-proBNP (BNP > 400 pg/ml or NT-proBNP > 450 pg/ml in persons younger 50 years old; > 900 pg/l in persons 51-75 years old; > 1800 pg/ml older than 75 years) #.
- criteria according to clinical guidelines 2020 Clinical practice guidelines for Chronic heart failure. Russian Journal of Cardiology. 2020;25(11):4083. (In Russ.) doi:10.15829/1560-4071-2020-4083
Who cannot join
- Acetazolamide therapy for a month before hospitalization.
- The expected intravenous use of inotropes, vasopressors or sodium nitroprusside at any time of the study.
- Exposure to nephrotoxic agents (e.g. contrast dye) is expected within the next 3 days.
- Hypersensitivity to acetazolamide, other sulfonamides and / or components of the drug.
- Systolic blood pressure <90 mmHg.
- Pregnancy and lactation.
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- Hypokalemia (potassium < 3.5 mmol/l).
- Hyponatremia (sodium <135 mmol/l).
- Severe chronic renal insufficiency (creatinine clearance less than 10 ml/min) or the use of renal replacement therapy or ultrafiltration at any time prior to inclusion in the study.
- Metabolic acidosis (bicarbonate less than 12 mmol/L).
- Severe anemia (Hb <70 g/L).
- Acute renal failure.
- Addison's disease.
- Decompensated diabetes mellitus.
- Emergency conditions (myocardial infarction, pulmonary embolism, acute myocarditis, pericarditis, aortic aneurysm).
- Cirrhosis of the liver with encephalopathy and liver failure.
- Congenital heart defects.
- Malignant neoplasm in the phase of active treatment or terminal form of cancer.
- Hypocorticism.
Trial locations and contacts
1 site in 1 country.
About this study
The main causes of chronic heart failure (CHF) are arterial hypertension and coronary artery disease, less often cardiomyopathy, pericarditis, metastatic myocardial lesions. It should be noted that up to 50% of patients have a preserved left ventricular ejection fraction (LVEF), while its prevalence is progressively increasing annually.
Acute decompensation of CHF is understood as a rapid increase in the severity of clinical manifestations (shortness of breath, severe arterial hypoxemia, the occurrence of arterial hypotension), which caused urgent medical treatment and emergency hospitalization in a patient already suffering from CHF. Decompensation of CHF requires intensification of treatment in order to stabilize the patient's condition. Strengthening diuretic therapy in addition to standard therapy helps to reduce edematous syndrome.
Read the detailed description
Chronic heart failure (CHF) is a syndrome caused by a violation of the heart's ability for contraction and relaxation, which is associated with an imbalance of vasoconstrictor and vasodilating neurohormonal systems, leading to hypoperfusion of organs and systems and the appearance of such complaints and signs as shortness of breath, weakness, palpitations, increased fatigue, swelling due to fluid congestion in the body.
An unfavorable prognosis, significant costs associated with excessive hospitalization of patients with this diagnosis require the development of clear criteria for the diagnosis and treatment of this condition. The variety of variants of the course of the disease, heterogeneous clinical characteristics of patients, difficulties in determining predisposing factors, unsufficient data on the pathogenetic features of the development of certain types of decompensation of CHF require an active scientific search in this direction and the development of modern clinically effective algorithms for the diagnosis and treatment of such patients The scientific hypothesis of the present study is that the use of acetazolamide in patients with decompensated HF at the hospital stage is accompanied by a significant regression of congestion compared to standard diuretic therapy (since randomization).
The investigators will anticipate that appointment of acetazolamide is accompanied by a decrease in the manifestation of edema syndrome.
- Conditions
- Chronic Heart Failure
- Being tested
- Acetazolamide
- Keywords
- acetazolamide, edema syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Also called diacarb
Acetazolamide is a diuretic with a mild diuretic effect. Inhibits the enzyme carbonic anhydrase in the proximal convoluted tubule of the nephron. Increases urinary excretion of sodium, potassium, bicarbonate ions, does not affect the excretion of chlorine ions; causes an increase in urine pH.
| Study group | Role | What they receive |
|---|---|---|
| a group with the use of acetazolamide | Experimental | acetazolamide is prescribed at a dose of 250 mg 3 times a day Receives: Drug: Acetazolamide |
| a group of standart therapy | No intervention | standart therapy includes main and additional medicine for treatment of chronic heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease of decompensation
achievement of compensation in accordance with the criteria for discontinuation of diuretic therapy.
Measured: 3 days
Secondary outcomes (11)
an increase of urine volume
an increase in the volume of urine excreted in the first 72 hours of hospitalization (from the moment of randomization)
Measured: 3 days
Weight loss
a decrease of the weight
Measured: 10 days
Natriuresis
Natriuresis (evaluation in daily urine)
Measured: 10 days
Duration of hospitalization
Duration of hospitalization
Measured: 10 days
Duration of stay in the ICU
Duration of stay in the ICU
Measured: 10 days
Death from any cause
Death from any cause within 90 days
Measured: 90 days
Death from cardiovascular diseases
Death from cardiovascular diseases within 90 days
Measured: 90 days
Death from decompensation of CHF or CHF
Death from decompensation of CHF or CHF within 90 days
Measured: 90 days
The number of pleural and pericardial punctures
The number of pleural and pericardial punctures performed during the period of hospitalization
Measured: 10 days
The number of points according to the SHOKS (clinical condition assessment scale) score
0 points - absence of clinical signs of heart failure, I class - less than or equal to 3 points; II class - from 4 to 6 points; III class - from 7 to 9 points; IV class - more than 9 points.
Measured: 10 days
6-minute walk test
6-minute walk test at discharge from the hospital
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 May 2023
- Primary completion28 Aug 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Acetazolamide is a diuretic with a mild diuretic effect which will be used for treatment
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samara State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dmitriy Duplyakov, Principal investigator, SamSMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802849
- Sponsor's protocol ID
- 001
- Acronym
- ORION-A
- Status last verified
- Oct 2026
- First submitted
- 22 Mar 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetazolamide Per os for Decompensation of Heart Failure
- ClinicalTrials.gov ID
- NCT05802849
- Acronym / sponsor ID
- ORION-A / 001
- Conditions
- Chronic Heart Failure
- Keywords
- acetazolamide, edema syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Samara State Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 7 Apr 2023 (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.
The main causes of chronic heart failure (CHF) are arterial hypertension and coronary artery disease, less often cardiomyopathy, pericarditis, metastatic myocardial lesions. It should be noted that up to 50% of patients have a preserved left ventricular ejection fraction (LVEF), while its prevalence is progressively increasing annually.
Acute decompensation of CHF is understood as a rapid increase in the severity of clinical manifestations (shortness of breath, severe arterial hypoxemia, the occurrence of arterial hypotension), which caused urgent medical treatment and emergency hospitalization in a patient already suffering from CHF. Decompensation of CHF requires intensification of treatment in order to stabilize the patient's condition. Strengthening diuretic therapy in addition to standard therapy helps to reduce edematous syndrome.
Detailed description
Chronic heart failure (CHF) is a syndrome caused by a violation of the heart's ability for contraction and relaxation, which is associated with an imbalance of vasoconstrictor and vasodilating neurohormonal systems, leading to hypoperfusion of organs and systems and the appearance of such complaints and signs as shortness of breath, weakness, palpitations, increased fatigue, swelling due to fluid congestion in the body.
An unfavorable prognosis, significant costs associated with excessive hospitalization of patients with this diagnosis require the development of clear criteria for the diagnosis and treatment of this condition. The variety of variants of the course of the disease, heterogeneous clinical characteristics of patients, difficulties in determining predisposing factors, unsufficient data on the pathogenetic features of the development of certain types of decompensation of CHF require an active scientific search in this direction and the development of modern clinically effective algorithms for the diagnosis and treatment of such patients The scientific hypothesis of the present study is that the use of acetazolamide in patients with decompensated HF at the hospital stage is accompanied by a significant regression of congestion compared to standard diuretic therapy (since randomization).
The investigators will anticipate that appointment of acetazolamide is accompanied by a decrease in the manifestation of edema syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Acetazolamide is a diuretic with a mild diuretic effect which will be used for treatment
| Arm | Type | Receives |
|---|---|---|
| a group with the use of acetazolamide | Experimental | Drug: Acetazolamideacetazolamide is prescribed at a dose of 250 mg 3 times a day |
| a group of standart therapy | No intervention | –standart therapy includes main and additional medicine for treatment of chronic heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women aged 18 years and older
- Decompensated CHF NYHA II-IV, which required intravenous administration of diuretics
- Any injection fraction of left ventricle*
- Signed informed consent to participate in the study.
Key exclusion criteria (19 listed)
- Acetazolamide therapy for a month before hospitalization.
- The expected intravenous use of inotropes, vasopressors or sodium nitroprusside at any time of the study.
- Exposure to nephrotoxic agents (e.g. contrast dye) is expected within the next 3 days.
- Hypersensitivity to acetazolamide, other sulfonamides and / or components of the drug.
- Systolic blood pressure <90 mmHg.
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 |
|---|---|---|
| AcetazolamideAlso: diacarbAcetazolamide is a diuretic with a mild diuretic effect. Inhibits the enzyme carbonic anhydrase in the proximal convoluted tubule of the nephron. Increases urinary excretion of sodium, potassium, bicarbonate ions, does not affect the excretion of chlorine ions; causes an increase in urine pH. | Drug | a group with the use of acetazolamide |
Primary outcome
decrease of decompensation
Time frame: 3 days
achievement of compensation in accordance with the criteria for discontinuation of diuretic therapy.
11 secondary outcomes
an increase of urine volume
Time frame: 3 days
Weight loss
Time frame: 10 days
Natriuresis
Time frame: 10 days
Duration of hospitalization
Time frame: 10 days
Duration of stay in the ICU
Time frame: 10 days
Death from any cause
Time frame: 90 days
Death from cardiovascular diseases
Time frame: 90 days
Death from decompensation of CHF or CHF
Time frame: 90 days
The number of pleural and pericardial punctures
Time frame: 10 days
The number of points according to the SHOKS (clinical condition assessment scale) score
Time frame: 10 days
6-minute walk test
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Dmitriy Duplyakov principal investigator
SamSMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetazolamide in people with Chronic Heart Failure, run by Samara State Medical University at 1 site in Russia.
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 6 inclusion and 19 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: finished, as of the sponsor's last update on 16 Oct 2026. 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 Russia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decrease of decompensation (time frame: 3 days). 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 16 Oct 2026.