Patient's Management Receiving Eplerenone Therapy (PERGAME)

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

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

Study Overview

• Status: Completed
• Conditions: Left Ventricular Dysfunction Post Myocardial Infarction
• Intervention / Treatment: Other: Prospective Observational

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.

• Study Type: Observational
• Enrollment (Actual): 160

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Eplerenone	Other: Prospective Observational; this is an observational study non interventional

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Other Notable Events in FAS Population	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.).	Baseline up to Month 12
Percentage of Participants With General Practitioner (GP) Consultation in FAS Population		Baseline up to Month 12
Number of Measurements Per Month for Kalaemia Levels in FAS Population	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.	Months 3, 6, 9, 12
Maximum Kalaemia Levels in Serum in FAS Population	The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L.	Baseline up to Month 12
Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population	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.	Baseline up to Month 12
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population	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.	Baseline, Months 3, 6, 9, 12
Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population	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.	Baseline

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: September 14, 2011
• First Submitted That Met QC Criteria: September 22, 2011
• First Posted (Estimate): September 26, 2011

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: November 29, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: patients with MI- on top of treatment add Eplerenone - assess LVEF and BP
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ventricular Dysfunction; Ventricular Dysfunction, Left
• Other Study ID Numbers: NRA6140035