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Acetazolamide Per os for Decompensation of Heart Failure (ORION-A)

Primary Purpose

Chronic Heart Failure

Status
Recruiting
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Acetazolamide
Sponsored by
Samara State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring acetazolamide, edema syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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. 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.

Sites / Locations

  • Samara state medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

a group with the use of acetazolamide

a group of standart therapy

Arm Description

acetazolamide is prescribed at a dose of 250 mg 3 times a day

standart therapy includes main and additional medicine for treatment of chronic heart failure

Outcomes

Primary Outcome Measures

decrease of decompensation
achievement of compensation in accordance with the criteria for discontinuation of diuretic therapy.

Secondary Outcome Measures

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)
Weight loss
a decrease of the weight
Natriuresis
Natriuresis (evaluation in daily urine)
Duration of hospitalization
Duration of hospitalization
Duration of stay in the ICU
Duration of stay in the ICU
Death from any cause
Death from any cause within 90 days
Death from cardiovascular diseases
Death from cardiovascular diseases within 90 days
Death from decompensation of CHF or CHF
Death from decompensation of CHF or CHF within 90 days
The number of pleural and pericardial punctures
The number of pleural and pericardial punctures performed during the period of hospitalization
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.
6-minute walk test
6-minute walk test at discharge from the hospital

Full Information

First Posted
March 22, 2023
Last Updated
June 30, 2023
Sponsor
Samara State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05802849
Brief Title
Acetazolamide Per os for Decompensation of Heart Failure
Acronym
ORION-A
Official Title
Acetazolamide Per os for Decompensation of Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samara State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
acetazolamide, edema syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Acetazolamide is a diuretic with a mild diuretic effect which will be used for treatment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
a group with the use of acetazolamide
Arm Type
Experimental
Arm Description
acetazolamide is prescribed at a dose of 250 mg 3 times a day
Arm Title
a group of standart therapy
Arm Type
No Intervention
Arm Description
standart therapy includes main and additional medicine for treatment of chronic heart failure
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Other Intervention Name(s)
diacarb
Intervention Description
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.
Primary Outcome Measure Information:
Title
decrease of decompensation
Description
achievement of compensation in accordance with the criteria for discontinuation of diuretic therapy.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
an increase of urine volume
Description
an increase in the volume of urine excreted in the first 72 hours of hospitalization (from the moment of randomization)
Time Frame
3 days
Title
Weight loss
Description
a decrease of the weight
Time Frame
10 days
Title
Natriuresis
Description
Natriuresis (evaluation in daily urine)
Time Frame
10 days
Title
Duration of hospitalization
Description
Duration of hospitalization
Time Frame
10 days
Title
Duration of stay in the ICU
Description
Duration of stay in the ICU
Time Frame
10 days
Title
Death from any cause
Description
Death from any cause within 90 days
Time Frame
90 days
Title
Death from cardiovascular diseases
Description
Death from cardiovascular diseases within 90 days
Time Frame
90 days
Title
Death from decompensation of CHF or CHF
Description
Death from decompensation of CHF or CHF within 90 days
Time Frame
90 days
Title
The number of pleural and pericardial punctures
Description
The number of pleural and pericardial punctures performed during the period of hospitalization
Time Frame
10 days
Title
The number of points according to the SHOKS (clinical condition assessment scale) score
Description
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.
Time Frame
10 days
Title
6-minute walk test
Description
6-minute walk test at discharge from the hospital
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitriy Duplyakov, MD
Phone
89277297273
Email
Duplyakov@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Olesya Rubanenko, MD
Phone
89371887780
Email
olesya.rubanenko@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitriy Duplyakov
Organizational Affiliation
SamSMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samara state medical university
City
Samara
ZIP/Postal Code
443099
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olesya Rubanenko
Phone
89371887780
Email
olesya.rubanenko@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Acetazolamide Per os for Decompensation of Heart Failure

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