Factors of Potentially Dangerous Drug Interactions in Patients With Cardiovascular Diseases and Multimorbidity

N/AActive Not RecruitingNCT07607574

National Medical Research Center for Therapy and Preventive Medicine120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Cardiovascular Diseases, Multimorbidity, Drug Interactions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Primary outcome measure

Occurrence of potentially dangerous drug interactions, including drug-drug, drug-herb, and drug-supplement interactions identified using predefined medication safety assessment criteria

Time frame: assessed at 6 months, and 12 months

Secondary Outcomes

Major adverse clinical outcomes

Occurrence of major adverse clinical outcomes, including: * all-cause mortality, * stroke, * myocardial infarction, * thromboembolic events, * hypertensive crisis, * clinically significant cardiac rhythm and conduction disorders associated with hemodynamic instability, * life-threatening cardiac arrhythmias, * cardiopulmonary resuscitation (CPR), * development of major bleeding while taking anticoagulants and antiplatelet agents, * hospitalizations due to decompensation of heart failure (HF), * severe allergic reaction

Time frame: assessed at 12 months