An observational study in Chronic Heart Failure, sponsored by Elpen Pharmaceutical Co. Inc.. Recruiting at 1 site in Greece. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-07-22.
Sponsored by Elpen Pharmaceutical Co. Inc. · Observational
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 .
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 .
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 210 is close to the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Elpen Pharmaceutical Co. Inc. is the lead sponsor of 45 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Heart Failure patients treated with eplerenone and torasemide
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.
Time frame: 6 months
CHQ-SAS (Chronic Heart failure Questionnaire - Self Administered format, Standardized questions)
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.
Time frame: 6 months
New York Heart Association (NYHA) classification
Changes from baseline in patients' New York Heart Association (NYHA) classification between the visits and at 6 months.
Time frame: 6 months
Morisky Medication Adherence Scale (MMAS-8)
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.
Time frame: 6 months
Body weight
The change in patients' body weight from baseline, between the visits and at 6-months from treatment initiation.
Time frame: 6 months
Dosage scheme
The record of torasemide titration.
Time frame: 6 months
Number of Adverse Events
The record of Adverse Events during the study conduct.
Time frame: 6 months
Plan to share: No
Started Mar 2024 (actual). Primary completion is estimated for Mar 2025, 12 months after the start.
Of 182 industry-sponsored observational studies under Heart Failure, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 57. This study's planned 12 months is below that.
Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
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