Patient's Management Receiving Eplerenone Therapy (PERGAME)

Pfizer

Status: Completed

Conditions: Left Ventricular Dysfunction Post Myocardial Infarction

Treatments: Other: Prospective Observational

Study type: Observational

Funder types: Industry

Identifiers

NCT01440049

NRA6140035

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

160 participants in 1 patient group

Eplerenone

Treatment:

Other: Prospective Observational