Status:
RECRUITING
TorasEmide Induced Effect on QoL and Clinical parameterS in paTients With chronIc heArt Failure Receiving Eplerenone.
Lead Sponsor:
Elpen Pharmaceutical Co. Inc.
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18-90 years
Brief Summary
Heart failure (HF) is a multisystemic disorder characterized by marked disturbances in the physiology of the circulatory system and a multitude of structural and functional changes in the myocardium t...
Detailed Description
Eplerenone is more specific in blocking aldosterone and therefore causes less gynecomastia. Eplerenone is indicated in addition to standard therapy including β-blockers to reduce the risk of cardiovas...
Eligibility Criteria
Inclusion
- Adult patients (≥ 18 years) with a diagnosis of Chronic Heart Failure (CHF)
- Patients who are on treatment with torasemide added on to eplerenone treatment, from 1 to 7 days before study initiation.
- Patients who are able to provide informed consent and follow study procedures and requirements.
Exclusion
- Patients with hypersensitivity to the active substance of torasemide, sulfonylureas or to any of the excipients mentioned in torasemide SmPC.
- Patients with renal failure with anuria.
- Patients in hepatic coma, or pro-coma.
- Patients with intolerance to galactose, complete lactase deficiency or glucose-galactose malabsorption.
- Patients with hypotension.
- Patients with cardiac arrhythmias.
- Patients with parallel treatment with aminoglycosides or cephalosporins.
- Patients with kidney dysfunction due to drugs that cause kidney damage.
- The addition during the study of other drugs with a direct effect on diuresis (such as other diuretics or SGLT2 inhibitors).
- Patients who are unable to comply with the study protocol procedures and requirements.
Key Trial Info
Start Date :
March 6 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06117722
Start Date
March 6 2024
End Date
December 31 2025
Last Update
July 22 2024
Active Locations (1)
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1
ATTIKON University Hospital
Athens, Attica, Greece, 12462