Factors of Potentially Dangerous Drug Interactions in Patients With Cardiovascular Diseases and Multimorbidity: a Prospective Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Occurrence of potentially dangerous drug interactions
研究概览
简要总结
This prospective observational registry aims to evaluate the prevalence and clinical significance of potentially dangerous drug interactions in outpatients with cardiovascular diseases and multimorbidity.
Adult patients attending outpatient cardiology care are enrolled after providing informed consent. Demographic data, comorbidities, laboratory findings, and detailed information on prescription drugs, over-the-counter medications, herbal products, and dietary supplements are collected using standardized questionnaires and medical record review.
Medication adherence is assessed using the NSEPh scale. Potentially inappropriate medications and potentially dangerous drug combinations are identified using internationally recognized criteria and tools, including the Beers Criteria, STOPP/START criteria, and the Medication Appropriateness Index (MAI).
Participants are followed for 12 months with reassessment at 6 and 12 months. During follow-up, investigators record potentially dangerous drug interactions, adverse drug reactions, and major clinical events, including cardiovascular complications and hospitalizations due to heart failure.
The registry is designed to improve understanding of medication safety in patients with cardiovascular diseases and multimorbidity in real-world outpatient practice.
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
- •All patients presenting for an outpatient appointment at the medical center of Alloro LLC with a confirmed cardiovascular disease (CVD) based on objective examination, complaints and medical history, clinical and instrumental examination conducted in accordance with Clinical Guidelines, with existing indications for drug therapy.age 18 years and older
- •presence of at least two non-cardiological chronic non-communicable diseases established by relevant specialists (with an official specialist's report provided, indicating the diagnosis), for each of which permanent or temporary drug therapy has been prescribed
- •signed informed consent
排除标准
- •absence of contact with the patient (cognitive impairment, significant reduction in vision or hearing complicating contact with the patient, impossibility of clarifying the medication history for other reasons, impossibility of obtaining consent to participate in the study, language barrier).
- •officially established legal incapacity of the patient.
- •refusal to sign the informed consent.
- •refusal to participate in the study.
结局指标
主要结局
Occurrence of potentially dangerous drug interactions
时间窗: assessed at baseline, 6 months, and 12 months
Occurrence of potentially dangerous drug interactions, including drug-drug, drug-herb, and drug-supplement interactions identified using predefined medication safety assessment criteria
次要结局
未报告次要终点