Patient's Management Receiving Eplerenone Therapy (PERGAME)
2018년 11월 29일 업데이트: 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
연구 개요
상태
완전한
개입 / 치료
상세 설명
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.
연구 유형
관찰
등록 (실제)
160
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Eplerenone
|
this is an observational study non interventional
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population
기간: 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
|
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Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline up to Month 12
|
Baseline up to Month 12
|
|
|
Percentage of Participants Hospitalized in FAS Population
기간: Baseline up to Month 12
|
Baseline up to Month 12
|
|
|
Number of Participants With Worsened Renal Function
기간: Baseline up to Month 12
|
Baseline up to Month 12
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Reason for Increased or Decreased Eplerenone Dose
기간: Baseline up to Month 12
|
Baseline up to Month 12
|
|
|
Number of Participants With Concomitant Cardiovascular Treatment in FAS Population
기간: 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
기간: 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
기간: Baseline up to Month 12
|
Baseline up to Month 12
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants With Other Notable Events in FAS Population
기간: 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
기간: Baseline up to Month 12
|
Baseline up to Month 12
|
|
|
Number of Measurements Per Month for Kalaemia Levels in FAS Population
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 9월 1일
기본 완료 (실제)
2010년 12월 1일
연구 완료 (실제)
2010년 12월 1일
연구 등록 날짜
최초 제출
2011년 9월 14일
QC 기준을 충족하는 최초 제출
2011년 9월 22일
처음 게시됨 (추정)
2011년 9월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 12월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 11월 29일
마지막으로 확인됨
2018년 11월 1일
추가 정보
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