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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiovascular Diseases Drug Interactions Multimorbidity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Medical Research Centre for Therapy and Preventive Medicine

Moscow, 101990, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Occurrence of potentially dangerous drug interactions

Time frame: 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 outcomes

Major adverse clinical outcomes

Time frame: 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

Sponsors and collaborators

Lead sponsor

National Medical Research Center for Therapy and Preventive Medicine

Other Gov

Registry information

Official study title

Factors of Potentially Dangerous Drug Interactions in Patients With Cardiovascular Diseases and Multimorbidity: a Prospective Registry Study

Acronym: FARMISS

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 26, 2026
Registry last updated: Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, Not Recruiting