Patient's Management Receiving Eplerenone Therapy

Pfizer160 enrolled

Overview

On a population of patients followed by an office-based cardiologist and treated with eplerenone, the objectives of the survey are: * To describe the characteristics of the population treated. * To describe the methods of use of eplerenone (posology, duration of treatment, medicinal combinations). * To describe the follow-up methods of the treatment. * To describe the possible interruptions of the treatment

A sample size in the region of N = 400 patients will allow this accuracy of estimation, as for this size, the half-width would be equal to 5% for a frequency of 50% corresponding to a confidence interval of maximum width. In view of the type of survey and the need for 12 months of monitoring in the context of standard practice, it may be anticipated that the drop-off rate will be about 20%. A sample size of N = 500 patients was therefore chosen.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Left Ventricular Dysfunction Post Myocardial Infarction

Interventions

Prospective ObservationalOTHER

this is an observational study non interventional

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

Inclusion Criteria: The following patients may be selected to participate in the survey: * Those undergoing treatment with eplerenone in accordance with the MA or not, with a known start date. * Those likely to be followed by the same physician for a minimal period of twelve months. Exclusion Criteria: * Severe Kidney Disease * Hyperkamiemia more than 5.5

Outcomes

Primary Outcomes

Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population

Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.

Time frame: Baseline

Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population

Time frame: Baseline

Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population

Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant.

Time frame: Month 3

Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population

Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.

Time frame: Month 6

Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population

Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.

Time frame: Month 9

Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population

Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.

Data from ClinicalTrials.gov

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Time frame: Month 12

Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population

Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.

Time frame: Baseline, Month 3

Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population

Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.

Time frame: Baseline, Month 6

Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population

Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.

Time frame: Baseline, Month 9

Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population

Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.

Time frame: Baseline, Month 12

Percentage of Participants Who Died in SAS Population