Cardiovascular DiseasesFARMISSNCT07607574
Factors of Potentially Dangerous Drug Interactions in Patients With Cardiovascular Diseases and Multimorbidity
An observational study of Cardiovascular Diseases and Multimorbidity, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Multimorbidity, Drug Interactions
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 25 Jan 2026to Jan 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
National Medical Research Centre for Therapy and Preventive Medicine
Moscow, 101990
About this study
Official title: Factors of Potentially Dangerous Drug Interactions in Patients With Cardiovascular Diseases and Multimorbidity: a Prospective Registry Study
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.
Read more
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
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: assessed at baseline, 6 months, and 12 months
Secondary outcomes (1)
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
Measured: assessed at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start25 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sergey Martsevich, M.D., Professor, Study director, National Medical Research Centre for Therapy and Preventive Medicine, Moscow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607574
- Sponsor's protocol ID
- 08-08/25
- Acronym
- FARMISS
- Status last verified
- Jun 2026
- First submitted
- 19 May 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors of Potentially Dangerous Drug Interactions in Patients With Cardiovascular Diseases and Multimorbidity: a Prospective Registry Study
- ClinicalTrials.gov ID
- NCT07607574
- Acronym / sponsor ID
- FARMISS / 08-08/25
- Conditions
- Cardiovascular Diseases, Multimorbidity, Drug Interactions
- Keywords
- drug interactions, cardiovascular diseases, multimorbidity, potentially dangerous combinations
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Study start
- 25 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Major adverse clinical outcomes
Time frame: assessed at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergey Martsevich, M.D., Professor study director
National Medical Research Centre for Therapy and Preventive Medicine, Moscow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Multimorbidity, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of potentially dangerous drug interactions (time frame: assessed at baseline, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.