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Patient's Management Receiving Eplerenone Therapy (PERGAME)

29. november 2018 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

160

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 95 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Eplerenone
Andet: Prospective Observational
this is an observational study non interventional

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Reason for Increased or Decreased Eplerenone Dose
Tidsramme: Baseline up to Month 12
Baseline up to Month 12
Number of Participants With Concomitant Cardiovascular Treatment in FAS Population
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline up to Month 12
Baseline up to Month 12

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Other Notable Events in FAS Population
Tidsramme: 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
Tidsramme: Baseline up to Month 12
Baseline up to Month 12
Number of Measurements Per Month for Kalaemia Levels in FAS Population
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2008

Primær færdiggørelse (Faktiske)

1. december 2010

Studieafslutning (Faktiske)

1. december 2010

Datoer for studieregistrering

Først indsendt

14. september 2011

Først indsendt, der opfyldte QC-kriterier

22. september 2011

Først opslået (Skøn)

26. september 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. november 2018

Sidst verificeret

1. november 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NRA6140035

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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