Patient's Management Receiving Eplerenone Therapy (PERGAME)
29 novembre 2018 aggiornato da: 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
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
160
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 95 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Eplerenone
|
this is an observational study non interventional
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline up to Month 12
|
Baseline up to Month 12
|
|
|
Percentage of Participants Hospitalized in FAS Population
Lasso di tempo: Baseline up to Month 12
|
Baseline up to Month 12
|
|
|
Number of Participants With Worsened Renal Function
Lasso di tempo: Baseline up to Month 12
|
Baseline up to Month 12
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants With Reason for Increased or Decreased Eplerenone Dose
Lasso di tempo: Baseline up to Month 12
|
Baseline up to Month 12
|
|
|
Number of Participants With Concomitant Cardiovascular Treatment in FAS Population
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline up to Month 12
|
Baseline up to Month 12
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants With Other Notable Events in FAS Population
Lasso di tempo: 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
Lasso di tempo: Baseline up to Month 12
|
Baseline up to Month 12
|
|
|
Number of Measurements Per Month for Kalaemia Levels in FAS Population
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2008
Completamento primario (Effettivo)
1 dicembre 2010
Completamento dello studio (Effettivo)
1 dicembre 2010
Date di iscrizione allo studio
Primo inviato
14 settembre 2011
Primo inviato che soddisfa i criteri di controllo qualità
22 settembre 2011
Primo Inserito (Stima)
26 settembre 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
19 dicembre 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 novembre 2018
Ultimo verificato
1 novembre 2018
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NRA6140035
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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