Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure)

Study Overview
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Brief Summary
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Secondary Data Collection Study; Safety And Effectiveness Of Selara Under Japanese Medical Practice

Detailed Description
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This study will be conducted under the central registration system until the number of subjects who meet the conditions for registration reaches the target number of subjects. The patients will be observed up until Week 52.

Official Title
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DRUG USE INVESTIGATION OF SELARA(REGISTERED). TABLETS(AN INVESTIGATION FOR CHRONIC HEART FAILURE)

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Drug: Eplerenone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in whom treatment with this drug is for CHF. The indications at approval for this drug are as follows. When using this drug, refer to the latest package insert of this drug. Exclusion Criteria: Patients who were previously registered for this study. Patients who received eplerenone within the past three months regardless of the reason for use.

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eplerenone<br>Patients with CHF receiving Selara (eplerenone) | Drug: Eplerenone<br>* In adults, usually, administer the initial dose of 25 mg once daily according to the patient's serum potassium level and conditions, increase dosage up to 50 mg once daily after 4 week; patients with moderate renal impairment should start with 25 mg every other day and the maximum dosage should be 25 mg once daily. Also, dose should be reduced or interrupted according to serum potassium level and patient's conditions.<br>* Other names: Selara;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Selara in a chronic heart failure participant with moderate renal impairment (≥30 mL/min and <50 mL/min in eCLCr) who received Selara. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Selara was assessed by the physician. | 52 weeks from the start date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Selara in a chronic heart failure participant who received Selara. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Selara was assessed by the physician. | 52 weeks from the start date | 
| The Number of Deaths (Overall Deaths) | Overall deaths were described with the number of deaths from any cause at the time of 52 weeks after the start of administration, regardless of the treatment status (completed or discontinued). | 52 weeks from the start date | 
| The Number of Deaths (Cardiovascular Deaths) | Cardiovascular deaths were described with the number of deaths defined as any death due to cardiac failure, myocardial infarction, arrhythmia (atrial fibrillation, atrial flutter, arrhythmia supraventricular, or ventricular arrhythmia), stroke or cerebrovascular attack, and other causes related to cardiovascular system at the time of 52 weeks after the start of administration, regardless of the treatment status (completed or discontinued). | 52 weeks from the start date | 
| The Overall Mortality Rate | The overall mortality rate was calculated by the incidence of all-cause death per observation time based on the person-year method (the number of deaths in 100 person-year). | 52 weeks from the start date | 
| The Cardiovascular-related Mortality Rate | The cardiovascular-related mortality rate was calculated by the incidence of cardiovascular-related death per observation time based on the person-year method (the number of deaths in 100 person-year). Cardiovascular deaths were defined as any death due to cardiac failure, myocardial infarction, arrhythmia (atrial fibrillation, atrial flutter, arrhythmia supraventricular, or ventricular arrhythmia), stroke or cerebrovascular attack, and other causes related to cardiovascular system at the time of 52 weeks after the start of administration, regardless of the treatment status (completed or discontinued). | 52 weeks from the start date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Selara, Chronic Heart Failure