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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-05

Study Completion Date

2020-07-15

Brief Summary

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

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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.

Conditions

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Chronic Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Eplerenone

Patients with CHF receiving Selara (eplerenone)

Eplerenone

Intervention Type DRUG

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.

Interventions

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Eplerenone

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.

Intervention Type DRUG

Other Intervention Names

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Selara

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.

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No