Skip to main content
OpenTrials
Completed

NCT Number: NCT01440049

Patient's Management Receiving Eplerenone Therapy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Left Ventricular Dysfunction Post Myocardial Infarction

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prospective Observational

Other

this is an observational study non interventional

Primary outcomes

  1. Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population

    Time frame: Baseline

    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.

  2. Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population

    Time frame: Baseline

    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.

  3. Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population

    Time frame: Month 3

    Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant.

  4. Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population

    Time frame: Month 6

    Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.

  5. Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population

    Time frame: Month 9

    Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.

  6. Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population

    Time frame: Month 12

    Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.

  7. Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population

    Time frame: Baseline, Month 3

    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.

  8. Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population

    Time frame: Baseline, Month 6

    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.

  9. Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population

    Time frame: Baseline, Month 9

    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.

  10. Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population

    Time frame: Baseline, Month 12

    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.

  11. Percentage of Participants Who Died in SAS Population

    Time frame: Baseline up to Month 12

  12. Percentage of Participants Hospitalized in FAS Population

    Time frame: Baseline up to Month 12

  13. Number of Participants With Worsened Renal Function

    Time frame: Baseline up to Month 12

Secondary outcomes

  1. Number of Participants With Reason for Increased or Decreased Eplerenone Dose

    Time frame: Baseline up to Month 12

  2. Number of Participants With Concomitant Cardiovascular Treatment in FAS Population

    Time frame: Baseline up to Month 12

    Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.

  3. Number of Participants With Concomitant Cardiovascular Treatment in SAS Population

    Time frame: Baseline up to Month 12

    Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.

  4. Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population

    Time frame: Baseline up to Month 12

Other outcomes

  1. Percentage of Participants With Other Notable Events in FAS Population

    Time frame: Baseline up to Month 12

    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.).

  2. Percentage of Participants With General Practitioner (GP) Consultation in FAS Population

    Time frame: Baseline up to Month 12

  3. Number of Measurements Per Month for Kalaemia Levels in FAS Population

    Time frame: Months 3, 6, 9, 12

    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.

  4. Maximum Kalaemia Levels in Serum in FAS Population

    Time frame: Baseline up to Month 12

    The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L.

  5. Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population

    Time frame: Baseline up to Month 12

    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.

  6. Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population

    Time frame: Baseline, Months 3, 6, 9, 12

    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.

  7. Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: PERGAME

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 26, 2011
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.