Cardiovascular Diseases, Drug Interactions, Multimorbidity
Conditions
Keywords
drug interactions, cardiovascular diseases, multimorbidity, potentially dangerous combinations
Brief summary
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.
Interventions
None listed
Sponsors
National Medical Research Center for Therapy and Preventive Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of potentially dangerous drug interactions | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse clinical outcomes | assessed at 12 months | 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 |
Countries
Russia
Contacts
STUDY_DIRECTORSergey Martsevich, M.D., Professor
National Medical Research Centre for Therapy and Preventive Medicine, Moscow
Outcome results
None listed