N/A
Completed N=160
Patient's Management Receiving Eplerenone Therapy
Left Ventricular Dysfunction Post Myocardial Infarction
Source: ClinicalTrials.gov NCT01440049 ↗
Enrolled (actual)
160
Serious AEs
10.6%
Results posted
Jan 2013
Primary outcomePrimary: Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population — 41.2 Percentage of EDV
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population |
41.2 | — |
| PRIMARY Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population |
41.40 | — |
| PRIMARY Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population |
98.9 | — |
| PRIMARY Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population |
95.8 | — |
| PRIMARY Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population |
94.8 | — |
| PRIMARY Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population |
94.3 | — |
| PRIMARY Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population |
0.7; 3.4; 84.5; 11.5; 4.5; 76.4 | — |
| PRIMARY Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population |
5.9; 70.6; 23.5 | — |
| PRIMARY Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population |
7.3; 60.0; 32.7 | — |
| PRIMARY Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population |
6.1; 78.8; 15.2 | — |
| PRIMARY Percentage of Participants Who Died in SAS Population |
6.1 | — |
| PRIMARY Percentage of Participants Hospitalized in FAS Population |
22.6 | — |
| PRIMARY Number of Participants With Worsened Renal Function |
— | — |
| SECONDARY Number of Participants With Reason for Increased or Decreased Eplerenone Dose |
— | — |
| SECONDARY Number of Participants With Concomitant Cardiovascular Treatment in FAS Population |
143 | — |
| SECONDARY Number of Participants With Concomitant Cardiovascular Treatment in SAS Population |
144 | — |
| SECONDARY Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population |
13.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT01440049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.