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Patient's Management Receiving Eplerenone Therapy (PERGAME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01440049
Recruitment Status : Completed
First Posted : September 26, 2011
Results First Posted : January 30, 2013
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date September 14, 2011
First Posted Date September 26, 2011
Results First Submitted Date December 21, 2012
Results First Posted Date January 30, 2013
Last Update Posted Date December 19, 2018
Study Start Date September 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2012)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Percentage of Participants Who Died in SAS Population [ Time Frame: Baseline up to Month 12 ]
  • Percentage of Participants Hospitalized in FAS Population [ Time Frame: Baseline up to Month 12 ]
  • Number of Participants With Worsened Renal Function [ Time Frame: Baseline up to Month 12 ]
Original Primary Outcome Measures
 (submitted: September 22, 2011)
  • left ventricular dysfonction at inclusion. [ Time Frame: 1 year ]
  • measurment of Eplerenone treatment compliance.change from baseline Eplerenone treatment dosage. [ Time Frame: 1 year ]
  • death happening during the follow up [ Time Frame: 1year ]
  • hospitalization [ Time Frame: 1year ]
  • worsening renal fonction [ Time Frame: 1year ]
Change History Complete list of historical versions of study NCT01440049 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 21, 2012)
  • Number of Participants With Reason for Increased or Decreased Eplerenone Dose [ Time Frame: Baseline up to Month 12 ]
  • 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.
  • 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.
  • Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population [ Time Frame: Baseline up to Month 12 ]
Original Secondary Outcome Measures
 (submitted: September 22, 2011)
  • demography patients characteristic; age, weight, smoke, gender. [ Time Frame: 1 Year ]
  • reason of increasing or decreasing eplerenone [ Time Frame: 1year ]
  • concomitant cardiovascular treatments (in addition to Eplerenone) [ Time Frame: 1year ]
  • Eplerenone discontinuation [ Time Frame: 1year ]
Current Other Pre-specified Outcome Measures
 (submitted: December 21, 2012)
  • 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.).
  • Percentage of Participants With General Practitioner (GP) Consultation in FAS Population [ Time Frame: Baseline up to Month 12 ]
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Left Ventricular Dysfunction Post Myocardial Infarction
Intervention Other: Prospective Observational
this is an observational study non interventional
Study Groups/Cohorts Eplerenone
Intervention: Other: Prospective Observational
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 25, 2012)
160
Original Actual Enrollment
 (submitted: September 22, 2011)
500
Actual Study Completion Date December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01440049
Other Study ID Numbers NRA6140035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018