Patient's Management Receiving Eplerenone Therapy (PERGAME)
29 november 2018 bijgewerkt door: Pfizer
Assessment Of Follow-Up Methods For Patients Treated In The Long-Term With A Specific Aldosterone Receptor Antagonist
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
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
160
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 95 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Eplerenone
|
this is an observational study non interventional
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population
Tijdsspanne: 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.
|
Baseline
|
|
Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population
Tijdsspanne: 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.
|
Baseline
|
|
Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population
Tijdsspanne: Month 3
|
Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant.
|
Month 3
|
|
Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population
Tijdsspanne: Month 6
|
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
|
Month 6
|
|
Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population
Tijdsspanne: Month 9
|
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
|
Month 9
|
|
Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population
Tijdsspanne: Month 12
|
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
|
Month 12
|
|
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population
Tijdsspanne: 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.
|
Baseline, Month 3
|
|
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population
Tijdsspanne: 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.
|
Baseline, Month 6
|
|
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population
Tijdsspanne: 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.
|
Baseline, Month 9
|
|
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population
Tijdsspanne: 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.
|
Baseline, Month 12
|
|
Percentage of Participants Who Died in SAS Population
Tijdsspanne: Baseline up to Month 12
|
Baseline up to Month 12
|
|
|
Percentage of Participants Hospitalized in FAS Population
Tijdsspanne: Baseline up to Month 12
|
Baseline up to Month 12
|
|
|
Number of Participants With Worsened Renal Function
Tijdsspanne: Baseline up to Month 12
|
Baseline up to Month 12
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Participants With Reason for Increased or Decreased Eplerenone Dose
Tijdsspanne: Baseline up to Month 12
|
Baseline up to Month 12
|
|
|
Number of Participants With Concomitant Cardiovascular Treatment in FAS Population
Tijdsspanne: 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.
|
Baseline up to Month 12
|
|
Number of Participants With Concomitant Cardiovascular Treatment in SAS Population
Tijdsspanne: 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.
|
Baseline up to Month 12
|
|
Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population
Tijdsspanne: Baseline up to Month 12
|
Baseline up to Month 12
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of Participants With Other Notable Events in FAS Population
Tijdsspanne: 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.).
|
Baseline up to Month 12
|
|
Percentage of Participants With General Practitioner (GP) Consultation in FAS Population
Tijdsspanne: Baseline up to Month 12
|
Baseline up to Month 12
|
|
|
Number of Measurements Per Month for Kalaemia Levels in FAS Population
Tijdsspanne: 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.
|
Months 3, 6, 9, 12
|
|
Maximum Kalaemia Levels in Serum in FAS Population
Tijdsspanne: 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.
|
Baseline up to Month 12
|
|
Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population
Tijdsspanne: 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.
|
Baseline up to Month 12
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Tijdsspanne: 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.
|
Baseline, Months 3, 6, 9, 12
|
|
Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population
Tijdsspanne: 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.
|
Baseline
|
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Sponsor
Publicaties en nuttige links
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2008
Primaire voltooiing (Werkelijk)
1 december 2010
Studie voltooiing (Werkelijk)
1 december 2010
Studieregistratiedata
Eerst ingediend
14 september 2011
Eerst ingediend dat voldeed aan de QC-criteria
22 september 2011
Eerst geplaatst (Schatting)
26 september 2011
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 december 2018
Laatste update ingediend die voldeed aan QC-criteria
29 november 2018
Laatst geverifieerd
1 november 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NRA6140035
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