Clinical trial NCT06117722: TorasEmide Induced Effect on QoL and Clinical parameterS in paTients With chronIc heArt Failure Receiving Eplerenone.
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Heart Failure
Lead sponsor: Elpen Pharmaceutical Co. Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a diagnosis of Chronic Heart Failure (CHF) who are on treatment with torasemide added on to eplerenone treatment, from 1 to 7 days before study initiation.

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 .

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 .

Eligibility 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.

Primary outcomes:
measure: Minnesota Living with Heart Failure (MLHF)
timeFrame: 6 months
Secondary outcomes:
measure: CHQ-SAS (Chronic Heart failure Questionnaire - Self Administered format, Standardized questions)
timeFrame: 6 months
measure: New York Heart Association (NYHA) classification
timeFrame: 6 months
measure: Morisky Medication Adherence Scale (MMAS-8)
timeFrame: 6 months
measure: Body weight
timeFrame: 6 months
measure: Dosage scheme
timeFrame: 6 months
measure: Number of Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: ATTIKON University Hospital
state: Attica
Study officials:
affiliation: Elpen Pharmaceutical Industry
name: Alexandros Ginis, MD
role: STUDY_DIRECTOR
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