Patient's Management Receiving Eplerenone Therapy (PERGAME)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01440049
First received: September 14, 2011
Last updated: December 21, 2012
Last verified: December 2012
  Purpose

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

Condition Intervention
Left Ventricular Dysfunction Post Myocardial Infarction
Other: Prospective Observational

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment Of Follow-Up Methods For Patients Treated In The Long-Term With A Specific Aldosterone Receptor Antagonist

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant.

  • Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.

  • Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
    Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.

  • Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.

  • Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population [ Time Frame: Baseline, Month 9 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Died in SAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Hospitalized in FAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
  • Number of Participants With Worsened Renal Function [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With Reason for Increased or Decreased Eplerenone Dose [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
  • Number of Participants With Concomitant Cardiovascular Treatment in FAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
    Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.

  • Number of Participants With Concomitant Cardiovascular Treatment in SAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
    Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.

  • Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Percentage of Participants With Other Notable Events in FAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
    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.).

  • Percentage of Participants With General Practitioner (GP) Consultation in FAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
  • Number of Measurements Per Month for Kalaemia Levels in FAS Population [ Time Frame: Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    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.

  • Maximum Kalaemia Levels in Serum in FAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
    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 From Baseline in Maximum Value of Kalaemia Levels in FAS Population [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population [ Time Frame: Baseline, Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Enrollment: 160
Study Start Date: September 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Eplerenone Other: Prospective Observational
this is an observational study non interventional

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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440049

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01440049     History of Changes
Other Study ID Numbers: NRA6140035
Study First Received: September 14, 2011
Results First Received: December 21, 2012
Last Updated: December 21, 2012
Health Authority: France: National Committee of Computing and Liberty

Keywords provided by Pfizer:
patients with MI- on top of treatment add Eplerenone - assess LVEF and BP

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ventricular Dysfunction, Left
Ventricular Dysfunction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014