Acetazolamide Per os for Decompensation of Heart Failure

Launched by SAMARA STATE MEDICAL UNIVERSITY · Apr 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called acetazolamide to help treat patients with chronic heart failure (CHF) who are experiencing a sudden worsening of their condition, known as acute decompensation. When a person's heart failure worsens, they may feel very short of breath, have low blood pressure, and need urgent medical care. The goal of this trial is to see if acetazolamide can improve symptoms and stabilize patients more effectively when used alongside standard treatments, particularly by helping to remove excess fluid from the body.

To participate in this trial, individuals must be at least 18 years old and have a diagnosis of decompensated CHF that requires intravenous diuretics (medications used to help remove fluid). Participants should be willing to give their consent to join the study. However, there are some criteria that could exclude someone from participating, such as recent treatment with acetazolamide, certain severe health conditions, or specific laboratory test results. If eligible, participants can expect to receive close monitoring and care while trying this new treatment option, which might help them feel better faster during a health crisis.

Gender

ALL

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.