Assessment Of Follow-Up Methods For Patients Treated In The Long-Term With A Specific Aldosterone Receptor Antagonist
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 160
- 主要终点
- Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Severe Kidney Disease
- •Hyperkamiemia more than 5.5
结局指标
主要结局
Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population
时间窗: 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.
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population
时间窗: 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.
Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population
时间窗: Month 3
Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant.
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population
时间窗: 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.
Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population
时间窗: 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.
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population
时间窗: 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.
Percentage of Participants Who Died in SAS Population
时间窗: Baseline up to Month 12
Percentage of Participants Hospitalized in FAS Population
时间窗: Baseline up to Month 12
Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population
时间窗: Month 6
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population
时间窗: Month 9
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population
时间窗: Month 12
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population
时间窗: 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.
Number of Participants With Worsened Renal Function
时间窗: Baseline up to Month 12
次要结局
- Number of Participants With Reason for Increased or Decreased Eplerenone Dose(Baseline up to Month 12)
- Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population(Baseline up to Month 12)
- Number of Participants With Concomitant Cardiovascular Treatment in FAS Population(Baseline up to Month 12)
- Number of Participants With Concomitant Cardiovascular Treatment in SAS Population(Baseline up to Month 12)