ESTIA: TorasEmide Induced Effect on Quality of Life and Clinical parameterS in paTients With chronIc heArt Failure Receiving Eplerenone.

Sponsor

Elpen Pharmaceutical Co. Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06117722

Collaborator

(none)

210

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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 that adversely affect the systolic function and diastolic filling of the heart. Heart failure is not a single pathologic diagnosis, but a clinical syndrome consisting of cardiac symptoms (eg, dyspnea, edema of the lower extremities, and fatigue) that may be accompanied by signs (eg, increased jugular venous pressure and peripheral edema).The diagnosis of CKD becomes more likely in patients with a history of myocardial infarction (MI), arterial hypertension, coronary artery disease (CHD), diabetes mellitus, alcohol abuse, chronic kidney disease (CKD), cardiotoxic chemotherapy, and in patients with a family history of cardiomyopathy or of sudden death. The diagnosis of HF requires the presence of HF symptoms and/or signs and objective evidence of cardiac dysfunction.

The main symptoms of HF are symptoms such as shortness of breath at rest or during exercise, difficulty breathing (dyspnea), rapid breathing (tachypnea), difficulty breathing when bending over (bendopnea), orthopnea, paroxysmal nocturnal dyspnea, fatigue , weight gain or weight loss, swelling (of the extremities, scrotum or elsewhere), wheezing, palpitations, syncope, history of Cheyne Stokes breathing during sleep (often reported by the family rather than the patient), cough, drowsiness.

The simplest terminology used to describe HF severity is the New York Heart Association (NYHA) functional classification based on symptom severity and physical activity.

In Greece, it is estimated that the number of patients suffering from HF is 200,000.

In the vast majority of cases, transthoracic echocardiography is the initial cardiac imaging test used to evaluate patients with newly diagnosed or suspected heart failure. Echocardiography is particularly suitable for the evaluation of myocardial structure and function, valvular function and hemodynamic parameters .

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure	Other: Eplerenone torasemide in chronic heart failure

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 cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (LVEF ≤40%) and clinical evidence of heart failure after recent myocardial infarction. In addition, eplerenone is indicated in standard optimal therapy to reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA class II (chronic) HF and with left ventricular systolic dysfunction (LVEF ≤ 30%).

Caution should be exercised when MRAs are used in patients with renal impairment and those with serum potassium concentrations >5.0 mmol/L.

Diuretics are drugs that are recommended or should be considered in selected HF patients with reduced ejection fraction. The goal of diuretic therapy is to achieve and maintain euvolemia with the lowest dose of diuretics.

Loop diuretics are recommended to reduce signs and/or symptoms of congestion in patients with HFrEF.

Transition to oral therapy should begin when the patient's clinical condition is stable .

Torasemide, one of the loop diuretics, is indicated in the treatment of edema due to congestive heart failure. The usual starting dose is 10 or 20 mg once a day. If the diuretic response is inadequate, the dose should be approximately doubled until an adequate response is achieved .

Among the potential advantages of torasemide in the treatment of HF are its beneficial pharmacological properties, which make it more suitable for the management of congestion ).

Torasemide may be less susceptible to diuretic resistance, has a prolonged half-life (3.5 hours), prolonged duration of effect (6-16 hours), and is less prone to hypokalemia .

Study Design

Study Type:

Observational

Anticipated Enrollment :

210 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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.

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

Minnesota Living with Heart Failure (MLHF) [6 months]
The change in the disease specific questionnaire - Minnesota Living with Heart Failure (MLHF) - score from baseline to 6 months of treatment and between the visits.

Secondary Outcome Measures

CHQ-SAS (Chronic Heart failure Questionnaire - Self Administered format, Standardized questions) [6 months]
Changes from baseline in the CHQ-SAS (Chronic Heart failure Questionnaire - Self Administered format, Standardized questions) to assess the degree of dyspnoea, between the visits and at 6 months from treatment initiation. Changes from baseline in patients' New York Heart Association (NYHA) classification between the visits and at 6 months.
New York Heart Association (NYHA) classification [6 months]
Changes from baseline in patients' New York Heart Association (NYHA) classification between the visits and at 6 months.
Morisky Medication Adherence Scale (MMAS-8) [6 months]
The score of the 8-item Morisky Medication Adherence Scale (MMAS-8) at 3 and 6 months from treatment initiation and its change between visits.
Body weight [6 months]
The change in patients' body weight from baseline, between the visits and at 6-months from treatment initiation.
Dosage scheme [6 months]
The record of torasemide titration.
Number of Adverse Events [6 months]
The record of Adverse Events during the study conduct.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Elpen Pharmaceutical Co. Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Elpen Pharmaceutical Co. Inc.

ClinicalTrials.gov Identifier:

NCT06117722

Other Study ID Numbers:

2023-TOREPL-EL-184

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Failure

Eplerenone

Torsemide

Study Results

No Results Posted as of Nov 7, 2023