Left Ventricular Dysfunction Post Myocardial Infarction Clinical Trial
— PERGAMEOfficial title:
Assessment Of Follow-Up Methods For Patients Treated In The Long-Term With A Specific Aldosterone Receptor Antagonist
| NCT number | NCT01440049 |
| Other study ID # | NRA6140035 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 2008 |
| Est. completion date | December 2010 |
| Verified date | November 2018 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | December 2010 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 95 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Percentage of Participants With Other Notable Events in FAS Population | 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.). | Baseline up to Month 12 | |
| Other | Percentage of Participants With General Practitioner (GP) Consultation in FAS Population | Baseline up to Month 12 | ||
| Other | Number of Measurements Per Month for Kalaemia Levels in FAS Population | 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. | Months 3, 6, 9, 12 | |
| Other | Maximum Kalaemia Levels in Serum in FAS Population | The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L. | Baseline up to Month 12 | |
| Other | Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population | 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. | Baseline up to Month 12 | |
| Other | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | 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. | Baseline, Months 3, 6, 9, 12 | |
| Other | Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population | 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. | Baseline | |
| Primary | Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population | 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. | Baseline | |
| Primary | Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population | 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. | Baseline | |
| Primary | Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population | Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant. | Month 3 | |
| Primary | Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population | Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant. | Month 6 | |
| Primary | Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population | Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant. | Month 9 | |
| Primary | Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population | Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant. | Month 12 | |
| Primary | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population | 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. | Baseline, Month 3 | |
| Primary | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population | 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. | Baseline, Month 6 | |
| Primary | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population | 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. | Baseline, Month 9 | |
| Primary | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population | 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. | Baseline, Month 12 | |
| Primary | Percentage of Participants Who Died in SAS Population | Baseline up to Month 12 | ||
| Primary | Percentage of Participants Hospitalized in FAS Population | Baseline up to Month 12 | ||
| Primary | Number of Participants With Worsened Renal Function | Baseline up to Month 12 | ||
| Secondary | Number of Participants With Reason for Increased or Decreased Eplerenone Dose | Baseline up to Month 12 | ||
| Secondary | Number of Participants With Concomitant Cardiovascular Treatment in FAS Population | Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study. | Baseline up to Month 12 | |
| Secondary | Number of Participants With Concomitant Cardiovascular Treatment in SAS Population | Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study. | Baseline up to Month 12 | |
| Secondary | Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population | Baseline up to Month 12 |