Patient's Management Receiving Eplerenone Therapy

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
Assessment Of Follow-Up Methods For Patients Treated In The Long-Term With A Specific Aldosterone Receptor Antagonist

Conditions
-----------------
Left Ventricular Dysfunction Post Myocardial Infarction

Intervention / Treatment
-----------------
* Other: Prospective Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eplerenone<br> | Other: Prospective Observational<br>* this is an observational study non interventional<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Month 12 | 
| Percentage of Participants Who Died in SAS Population |  | Baseline up to Month 12 | 
| Percentage of Participants Hospitalized in FAS Population |  | Baseline up to Month 12 | 
| Number of Participants With Worsened Renal Function |  | Baseline up to Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Reason for Increased or Decreased Eplerenone Dose |  | Baseline up to Month 12 | 
| Number of Participants With Concomitant Cardiovascular Treatment in FAS Population | Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study. | Baseline up to Month 12 | 
| Number of Participants With Concomitant Cardiovascular Treatment in SAS Population | Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study. | Baseline up to Month 12 | 
| Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population |  | Baseline up to Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients with MI- on top of treatment add Eplerenone - assess LVEF and BP