Clinical trial NCT01440049: Patient's Management Receiving Eplerenone Therapy
Official title: Assessment Of Follow-Up Methods For Patients Treated In The Long-Term With A Specific Aldosterone Receptor Antagonist
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Dysfunction Post Myocardial Infarction
Keywords: patients with MI- on top of treatment add Eplerenone - assess LVEF and BP
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-26
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population
timeFrame: Baseline
measure: Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population
timeFrame: Baseline
measure: Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population
timeFrame: Month 3
measure: Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population
timeFrame: Month 6
measure: Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population
timeFrame: Month 9
measure: Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population
timeFrame: Month 12
measure: Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population
timeFrame: Baseline, Month 3
measure: Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population
timeFrame: Baseline, Month 6
measure: Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population
timeFrame: Baseline, Month 9
measure: Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population
timeFrame: Baseline, Month 12
measure: Percentage of Participants Who Died in SAS Population
timeFrame: Baseline up to Month 12
measure: Percentage of Participants Hospitalized in FAS Population
timeFrame: Baseline up to Month 12
measure: Number of Participants With Worsened Renal Function
timeFrame: Baseline up to Month 12
Secondary outcomes:
measure: Number of Participants With Reason for Increased or Decreased Eplerenone Dose
timeFrame: Baseline up to Month 12
measure: Number of Participants With Concomitant Cardiovascular Treatment in FAS Population
timeFrame: Baseline up to Month 12
measure: Number of Participants With Concomitant Cardiovascular Treatment in SAS Population
timeFrame: Baseline up to Month 12
measure: Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population
timeFrame: Baseline up to Month 12
Other outcomes:
measure: Percentage of Participants With Other Notable Events in FAS Population
timeFrame: Baseline up to Month 12
measure: Percentage of Participants With General Practitioner (GP) Consultation in FAS Population
timeFrame: Baseline up to Month 12
measure: Number of Measurements Per Month for Kalaemia Levels in FAS Population
timeFrame: Months 3, 6, 9, 12
measure: Maximum Kalaemia Levels in Serum in FAS Population
timeFrame: Baseline up to Month 12
measure: Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population
timeFrame: Baseline up to Month 12
measure: Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population
timeFrame: Baseline
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: