Patient's Management Receiving Eplerenone Therapy (PERGAME)
2018年11月29日 更新者：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
研究概览
地位
完全的
详细说明
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.
研究类型
观察性的
注册 (实际的)
160
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 95年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Eplerenone
|
this is an observational study non interventional
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Baseline up to Month 12
|
Baseline up to Month 12
|
|
|
Percentage of Participants Hospitalized in FAS Population
大体时间：Baseline up to Month 12
|
Baseline up to Month 12
|
|
|
Number of Participants With Worsened Renal Function
大体时间：Baseline up to Month 12
|
Baseline up to Month 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Reason for Increased or Decreased Eplerenone Dose
大体时间：Baseline up to Month 12
|
Baseline up to Month 12
|
|
|
Number of Participants With Concomitant Cardiovascular Treatment in FAS Population
大体时间：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
大体时间：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
大体时间：Baseline up to Month 12
|
Baseline up to Month 12
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants With Other Notable Events in FAS Population
大体时间：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
大体时间：Baseline up to Month 12
|
Baseline up to Month 12
|
|
|
Number of Measurements Per Month for Kalaemia Levels in FAS Population
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
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赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年9月1日
初级完成 (实际的)
2010年12月1日
研究完成 (实际的)
2010年12月1日
研究注册日期
首次提交
2011年9月14日
首先提交符合 QC 标准的
2011年9月22日
首次发布 (估计)
2011年9月26日
研究记录更新
最后更新发布 (实际的)
2018年12月19日
上次提交的符合 QC 标准的更新
2018年11月29日
最后验证
2018年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.