Actively Recruiting
Acetazolamide Per os for Decompensation of Heart Failure
Led by Samara State Medical University · Updated on 2024-11-05
400
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of acetazolamide in patients with decompensated chronic heart failure (CHF), a condition where the heart struggles with contraction and relaxation leading to symptoms like shortness of breath, swelling, and fatigue. CHF often results from high blood pressure or coronary artery disease, and about half of patients have a preserved left ventricular ejection fraction. This trial aims to study whether adding acetazolamide to standard diuretic therapy can reduce congestion and improve patient outcomes during acute heart failure worsening. Participants will be randomly assigned to either receive acetazolamide at a dose of 250 mg three times daily along with standard heart failure medications, or to receive standard therapy alone. The study focuses on the hospital stage of decompensation treatment, evaluating the effect of acetazolamide on reducing fluid retention and edema compared to usual care. Throughout the study, participants will be monitored for changes in decompensation over three days, urine output, weight loss, natriuresis, hospital and ICU stay duration, and survival up to 90 days. Clinical assessments will include symptom scoring and a 6-minute walk test. The trial includes follow-up assessments up to 90 days after treatment to evaluate longer-term outcomes and safety.
CONDITIONS
Brief Title
Acetazolamide Per os for Decompensation of Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 years and older
- Decompensated chronic heart failure NYHA class II-IV requiring intravenous diuretics
- Any left ventricular ejection fraction
- Signed informed consent to participate
- For patients with ejection fraction ≥ 50%, presence of structural heart changes or elevated BNP/NT-proBNP levels according to clinical guidelines
You will not qualify if you...
- Acetazolamide use within one month before hospitalization
- Expected intravenous use of inotropes, vasopressors, or sodium nitroprusside during the study
- Expected exposure to nephrotoxic agents within three days
- Allergy to acetazolamide, sulfonamides, or drug components
- Systolic blood pressure below 90 mmHg
- Pregnancy or lactation
- Low potassium (below 3.5 mmol/l) or low sodium (below 135 mmol/l)
- Severe chronic kidney failure or dialysis
- Metabolic acidosis (bicarbonate below 12 mmol/l)
- Severe anemia (hemoglobin below 70 g/l)
- Acute kidney failure
- Addison's disease
- Decompensated diabetes mellitus
- Emergency conditions like myocardial infarction or pulmonary embolism
- Liver cirrhosis with encephalopathy or failure
- Congenital heart defects
- Active or terminal cancer
- Hypocorticism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 3 to 10 days
Participants receive acetazolamide or standard therapy to treat decompensated chronic heart failure and monitor the regression of congestion and other heart failure symptoms.
Daily visits during hospitalization for up to 10 days
Duration - Up to 90 days
Participants are monitored for safety and outcomes including survival and heart failure status after treatment ends.
Periodic follow-up visits or contacts up to 90 days after treatment
Trial Site Locations
Total: 1 location
1
Samara state medical university
Samara, Russia, 443099
Actively Recruiting
Research Team
D
Dmitriy Duplyakov, MD
O
Olesya Rubanenko, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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