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Patient's Management Receiving Eplerenone Therapy (PERGAME)

29. November 2018 aktualisiert von: 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

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

160

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 95 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Kohorte
  • Zeitperspektiven: Interessent

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Eplerenone
Sonstiges: Prospective Observational
this is an observational study non interventional

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline up to Month 12
Baseline up to Month 12
Percentage of Participants Hospitalized in FAS Population
Zeitfenster: Baseline up to Month 12
Baseline up to Month 12
Number of Participants With Worsened Renal Function
Zeitfenster: Baseline up to Month 12
Baseline up to Month 12

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Reason for Increased or Decreased Eplerenone Dose
Zeitfenster: Baseline up to Month 12
Baseline up to Month 12
Number of Participants With Concomitant Cardiovascular Treatment in FAS Population
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline up to Month 12
Baseline up to Month 12

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Other Notable Events in FAS Population
Zeitfenster: 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
Zeitfenster: Baseline up to Month 12
Baseline up to Month 12
Number of Measurements Per Month for Kalaemia Levels in FAS Population
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pfizer

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2008

Primärer Abschluss (Tatsächlich)

1. Dezember 2010

Studienabschluss (Tatsächlich)

1. Dezember 2010

Studienanmeldedaten

Zuerst eingereicht

14. September 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. September 2011

Zuerst gepostet (Schätzen)

26. September 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. Dezember 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. November 2018

Zuletzt verifiziert

1. November 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NRA6140035

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