Acetazolamide Per os for Decompensation of Heart Failure

NCT05802849 | Recruiting Phase 4

• 1 other identifier: 001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure

Keywords

acetazolamide; edema syndrome

Outcome Measures

Primary Outcomes (1)

• decrease of decompensation

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

  3 days

Secondary Outcomes (11)

• an increase of urine volume

  3 days

• Weight loss

  10 days

• Natriuresis

  10 days

• Duration of hospitalization

  10 days

• Duration of stay in the ICU

  10 days

Study Arms (2)

a group with the use of acetazolamide

EXPERIMENTAL

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

Drug: Acetazolamide

a group of standart therapy

NO INTERVENTION

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

Interventions

Acetazolamide DRUG

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.

Also known as: diacarb

a group with the use of acetazolamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Samara State Medical University: lead

Study Sites (1)

Samara state medical university

Samara, 443099, Russia

RECRUITING

MeSH Terms

Interventions

Acetazolamide

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dmitriy Duplyakov

  SamSMU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitriy Duplyakov, MD

CONTACT

89277297273; Duplyakov@yahoo.com

Olesya Rubanenko, MD

CONTACT

89371887780; olesya.rubanenko@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Acetazolamide is a diuretic with a mild diuretic effect which will be used for treatment

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 7, 2023
• Study Start: May 1, 2023
• Primary Completion: August 28, 2025
• Study Completion: December 1, 2025
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)