Patient's Management Receiving Eplerenone Therapy (PERGAME)

• Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  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.
• Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  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.
• Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant.
• Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
• Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
  Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
• Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
• Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
  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.
• Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
  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.
• Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population [ Time Frame: Baseline, Month 9 ] [ Designated as safety issue: No ]
  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.
• Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
  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.
• Percentage of Participants Who Died in SAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: Yes ]
• Percentage of Participants Hospitalized in FAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
• Number of Participants With Worsened Renal Function [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]

• measurment of Eplerenone treatment compliance.change from baseline Eplerenone treatment dosage. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• left ventricular dysfonction at inclusion. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• death happening during the follow up [ Time Frame: 1year ] [ Designated as safety issue: No ]
• hospitalisation [ Time Frame: 1year ] [ Designated as safety issue: No ]
• worsening renal fonction [ Time Frame: 1year ] [ Designated as safety issue: No ]

• Number of Participants With Reason for Increased or Decreased Eplerenone Dose [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
• Number of Participants With Concomitant Cardiovascular Treatment in FAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
  Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.
• Number of Participants With Concomitant Cardiovascular Treatment in SAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
  Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.
• Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]

• demography patients characteristic; age, weight, smoke, gender. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
• reason of increasing or decreasing eplerenone [ Time Frame: 1year ] [ Designated as safety issue: No ]
• concomitant cardiovascular treatments (in addition to Eplerenone) [ Time Frame: 1year ] [ Designated as safety issue: No ]
• Eplerenone discontinuation [ Time Frame: 1year ] [ Designated as safety issue: No ]

• Percentage of Participants With Other Notable Events in FAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
  Other notable events included any clinically significant event other than death or hospitalization (example, ventricular tachycardia treated by defibrillator, imbalanced diabetes, work accident, right foot gout crisis, low back pain-oliguria, chest pain, bronchitis, renal failure, heart failure, hypotension, edema, standardization of gamma glutamyl transpeptidase (GT) after stopping lamisyl (peros) prescribed for a long term for mycosis, pain, nausea, fracture, trauma, gonarthrosis, increased urea, elevation of gamma GT etc.).
• Percentage of Participants With General Practitioner (GP) Consultation in FAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
• Number of Measurements Per Month for Kalaemia Levels in FAS Population [ Time Frame: Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
  The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 millimole per liter (mmol/L). Number of measurements per month for the kalaemia levels was reported.
• Maximum Kalaemia Levels in Serum in FAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
  The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L.
• Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
  The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L. Change in maximum value kalaemia level was calculated by subtracting the baseline values from the maximum observed value of kalaemia levels during the study.
• Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population [ Time Frame: Baseline, Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
  New York Health Association (NYHA) functional classification included: Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity; fatigue, palpitation, or dyspnea with ordinary physical activity), Class III (marked limitation of physical activity; fatigue, palpitation, or dyspnea with less than ordinary physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Percentage of participants in each functional class was reported.
• Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  Reasons for starting eplerenone treatment included myocardial infarction, heart failure and other conditions including severe hypertension by primary hyperaldosteronism; hypertension/coronaropathy and hypokalaemia; hypertension; left ventricular failure; not tolerated spironolactone; hypertension: gynecomastia with aldactone; pulmonary suboedema; hypertension: adrenal hyperplasia, gynecomastia with aldactone; hypertension not controlled.

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.

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.

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