TorasEmide Induced Effect on QoL and Clinical parameterS in paTients With chronIc heArt Failure Receiving Eplerenone. (ESTIA)

July 18, 2024 updated by: Elpen Pharmaceutical Co. Inc.

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.

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 12462
        • Recruiting
        • Attikon University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minnesota Living with Heart Failure (MLHF)
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CHQ-SAS (Chronic Heart failure Questionnaire - Self Administered format, Standardized questions)
Time Frame: 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.
6 months
New York Heart Association (NYHA) classification
Time Frame: 6 months
Changes from baseline in patients' New York Heart Association (NYHA) classification between the visits and at 6 months.
6 months
Morisky Medication Adherence Scale (MMAS-8)
Time Frame: 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.
6 months
Body weight
Time Frame: 6 months
The change in patients' body weight from baseline, between the visits and at 6-months from treatment initiation.
6 months
Dosage scheme
Time Frame: 6 months
The record of torasemide titration.
6 months
Number of Adverse Events
Time Frame: 6 months
The record of Adverse Events during the study conduct.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elpen Pharmaceutical Co. Inc.

Investigators

  • Study Director: Alexandros Ginis, MD, Elpen Pharmaceutical Industry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

July 22, 2024

Last Update Submitted That Met QC Criteria

July 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-TOREPL-EL-184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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