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New treatment option for Chronic Heart Failure
Official title Acetazolamide Per os for Decompensation of Heart Failure
ClinicalTrials.gov ID: NCT05802849
What this study is testing
What is Acetazolamide?
Acetazolamide is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for chronic heart failure.
Also referred to as diacarb.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join 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.
See the full eligibility 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Samara, Russia
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Samara, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.