PLASMA Chile (PLASMA Chile)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 6
- 主要终点
- Identify the main epidemiological and clinical characteristics of patients with Heart Failure with reduced ejection fraction, as well as the medical treatment models used.
研究概览
简要总结
Prospective, multicenter, observational cohort study to collect data on Chilean patients diagnosed with Heart Failure with reduced ejection fraction, their treatments, and their progress in a real-world environment. Additional objectives will be analyzed, such as mortality, and the barriers, if any, to receiving the indicated treatment.
详细描述
Identify the main epidemiological and clinical characteristics of patients with Heart Failure with reduced ejection fraction, as well as the medical treatment models used.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥18 years old.
- •Patients with Heart Failure with Left Ventricular Ejection Fraction (LVEF) ≤ 40% will be included.
- •Patients must be willing to comply with the study requirements and complete the Informed Consent Form (defined as the legally valid and documented confirmation of a patient's voluntary agreement to participate in the clinical study).
排除标准
- •Patients without Heart Failure or with Heart Failure with Left Ventricular Ejection Fraction (LVEF)> 40%.
- •Patients unable to comply with the Clinical Investigation Plan.
- •Patients who are already enrolled or plan to participate in a concurrent clinical study of any medication and/or device at any time during the course of this clinical study without prior documented approval of the Medtronic Study Manager.
结局指标
主要结局
Identify the main epidemiological and clinical characteristics of patients with Heart Failure with reduced ejection fraction, as well as the medical treatment models used.
时间窗: 1 year
Patient´s baseline characteristics, medical history, socio-economic data, ancillary studies, laboratory tests, and cardiovascular medication will be summarized using summary statistics. Continuous variables will be presented using mean, standard deviation (SD), minimum, median, maximum, and interquartile range (IQR). Categorical variables will be presented as frequency and percentage.
次要结局
- Determine the prescription rate of a cardiac medical device in patients with Heart Failure with reduced ejection fraction(1 year)
- Determine the mortality rate and its classification in patients with Heart Failure with reduced ejection fraction during a 12-month period.(1 year)
- Determine the hospitalization rate for heart failure during the 12-month follow-up.(1 year)
- Determine the population with a profile of 1.5 primary prevention of sudden cardiac death(1 year)
- Determine the prescription rate of a cardiovascular pharmacological treatment in patients with Heart Failure with reduced ejection fraction(1 year)
- Determine the implant rate of a cardiac medical device in patients with Heart Failure with reduced ejection fraction(1 year)
- Identify the barriers, if any, to prescribing and implanting a cardiac medical device in those patients with a Class I recommendation according to the ACC/AHA/HRS 2017 guidelines.(1 year)