Prospective Observational Study of Polypharmacy, Safety, and Medication Adherence in Patients With HFrEF and HFmrEF: Data From the FARAON Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 1
研究概览
简要总结
This prospective registry study (FARAON) aims to assess the prevalence, structure, safety profile, and dynamics of polypharmacy, as well as its association with medication adherence, quality of life, and clinical outcomes in multimorbid patients with HFrEF and HFmrEF, aiming to identify potentially inappropriate prescribing (over/mis/underprescribing) and determine factors linked to low adherence and adverse events.
详细描述
The proposed statistical analysis plan for validating the Modified Express Module focuses on comparing biomarker levels and echocardiographic data between patients with true and declarative adherence, using the two-step Spearman correlation analysis for construct validation. To secure intellectual property, the description emphasizes methodological steps-specifically, analyzing correlations before and after excluding high-lie-score patients-without disclosing the specific proprietary questionnaires used, masking them under functional terms.
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
- •Patients with a confirmed diagnosis of chronic heart failure with reduced or mildly reduced ejection fraction (HFrEF / HFmrEF).
- •Diagnosis of HFrEF or HFmrEF confirmed by echocardiography within 3 months prior to enrollment.
- •Signed informed consent.
排除标准
- •Documented mental disorders.
- •Severe cognitive impairment
结局指标
主要结局
未指定
次要结局
- Health literacy level assessed by a specialized screening tool(Baseline)
- Response validity score assessed by the Modified Express Module(Baseline)