NCT07460531招募中不适用
Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure
LMU Klinikum2 个研究点 分布在 2 个国家目标入组 2,000 人开始时间: 2025年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Time to death from any cause
研究概览
简要总结
SOPHIE is a prospective, multicentre, observational cohort study aiming to enrol 2,000 CHF patients. Baseline assessments include validated PA questionnaires (GPAQ, IPAQ, KCCQ) and seven-day step counts from commercially available pedometer devices. Follow-up is conducted every six months via telephone, repeating PA assessments and recording cardiovascular events, hospitalisations, and patient-reported outcomes.
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
- •Heart failure NT-proBNP >600 pg/ml (at least once in the history) NYHA-Class II-IV HFrEF - heart failure with reduced ejection fraction; LVEF ≤40% or HFmrEF - heart failure with mildly reduced ejection fraction; LVEF 41% - 49% or HFpEF - heart failure with preserved ejection fraction; LVEF ≥50%
- •Age ≥18 years old
- •Willingness to participate in the study, confirmed by a signed informed consent form
- •Ownership of a pedometer (e.g. smartwatch, activity tracker, smartphone-app, analogical pedometer)
排除标准
- •Disease or disability that prevents physical activity
- •Hospitalisation due to heart failure within the last three months
结局指标
主要结局
Time to death from any cause
时间窗: 3 years
Time to cardiovascular death
时间窗: 3 years
Time to first heart failure related hospitalization
时间窗: 3 years
次要结局
未报告次要终点
研究者
Prof. Dr. Stefan Brunner
Principal Investigator
LMU Klinikum
研究点 (2)
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