Effect of Torasemide on Quality of Life in Heart Failure Patients Taking Eplerenone
ESTIA: TorasEmide Induced Effect on Quality of Life and Clinical parameterS in paTients With chronIc heArt Failure Receiving Eplerenone. Multicenter, Non-interventional, Prospective, Observational Clinical Study.
This study tests if adding torasemide to the treatment of heart failure patients already taking eplerenone can improve their quality of life and symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Elpen Pharmaceutical Co. Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Athens, Attica) |
| Trial ID | NCT06117722 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of torasemide, a loop diuretic, on the quality of life and clinical parameters in adult patients diagnosed with chronic heart failure who are also receiving eplerenone. The study focuses on patients who have been on torasemide treatment for 1 to 7 days prior to the study initiation. It aims to assess how the addition of torasemide affects symptoms and overall well-being in this patient population. The study will involve monitoring various clinical outcomes and patient-reported quality of life measures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of chronic heart failure currently treated with eplerenone and torasemide.
Not a fit: Patients with severe renal impairment, hypersensitivity to torasemide, or those experiencing significant cardiac arrhythmias may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of chronic heart failure by enhancing patient quality of life through optimized diuretic therapy.
How similar studies have performed: While the specific combination of torasemide and eplerenone in chronic heart failure is less commonly studied, similar approaches using diuretics in heart failure management have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Athens, Attica
- ATTIKON University Hospital — Athens, Attica, Greece (Recruiting)
Study contacts
- Study coordinator: Polyanthi Papanastasiou
- Email: p.papanastasiou@elpen.gr
- Phone: +302111865777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.