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

NCT06117722 | Recruiting

• 1 other identifier: 2023-TOREPL-EL-184
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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 .

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Minnesota Living with Heart Failure (MLHF)

  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 Outcomes (6)

• CHQ-SAS (Chronic Heart failure Questionnaire - Self Administered format, Standardized questions)

  6 months

• New York Heart Association (NYHA) classification

  6 months

• Morisky Medication Adherence Scale (MMAS-8)

  6 months

• Body weight

  6 months

• Dosage scheme

  6 months

Interventions

Eplerenone torasemide in chronic heart failure OTHER

Heart Failure patients treated with eplerenone and torasemide

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (1)

ATTIKON University Hospital

Athens, Attica, 12462, Greece

RECRUITING

Related Publications (29)

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Study Officials

• Alexandros Ginis, MD

  Elpen Pharmaceutical Industry

  STUDY DIRECTOR

Central Study Contacts

Polyanthi Papanastasiou

CONTACT

+302111865777; p.papanastasiou@elpen.gr

Alexandros Ginis

CONTACT

aginis@elpen.gr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: March 6, 2024
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)