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

NCT07607574 | Active Not Recruiting

• 1 other identifier: 08-08/25
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Multimorbidity; Drug Interactions

Keywords

drug interactions; cardiovascular diseases; multimorbidity; potentially dangerous combinations

Outcome Measures

Primary Outcomes (1)

• Occurrence of potentially dangerous drug interactions

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

  assessed at baseline, 6 months, and 12 months

Secondary Outcomes (1)

• Major adverse clinical outcomes

  assessed at 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included adult patients aged ≥18 years who attended an outpatient appointment at Alloro LLC Medical Center, had confirmed cardiovascular disease requiring pharmacotherapy, and had at least two non-cardiac chronic non-communicable diseases diagnosed by relevant specialists and requiring prescribed drug treatment. All participants provided written informed consent.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead

Study Sites (1)

National Medical Research Centre for Therapy and Preventive Medicine

Moscow, 101990, Russia

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Sergey Martsevich, M.D., Professor

  National Medical Research Centre for Therapy and Preventive Medicine, Moscow

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: January 25, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)