Using acetazolamide to treat worsening heart failure

Acetazolamide Per os for Decompensation of Heart Failure

This study is testing if acetazolamide can help adults with worsening heart failure feel better by reducing fluid buildup more effectively than regular diuretics.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Samara State Medical University (Academic / other)
• Locations: 1 site (Samara)
• Trial ID: NCT05802849 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of acetazolamide in patients experiencing acute decompensation of chronic heart failure (CHF). The study aims to determine if acetazolamide can significantly reduce symptoms of fluid congestion compared to standard diuretic therapy. Participants will be adults aged 18 and older with decompensated CHF requiring intravenous diuretics. The trial will involve randomization to assess the impact of acetazolamide on edema and other clinical manifestations of CHF.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with decompensated CHF requiring intravenous diuretics.

Not a fit: Patients who have received acetazolamide therapy within the month prior to hospitalization may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for managing fluid retention in patients with worsening heart failure.

How similar studies have performed: While the use of acetazolamide in heart failure is not widely tested, similar studies have shown promise in managing fluid retention in other conditions.

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.

Where this trial is running

Samara

• Samara state medical university — Samara, Russia (Recruiting)

Study contacts

• Principal investigator: Dmitriy Duplyakov — SamSMU
• Study coordinator: Dmitriy Duplyakov, MD

Conditions Chronic Heart Failure; acetazolamide; edema syndrome