Atrial FibrillationINTELLECTIINCT05367141
Improvement Adherence to Clinical Practice Guidelines Using the Clinical Decision Support System in Patients With Hypertension and Atrial Fibrillation
A study testing CDSS ("MedicBK") in people with Atrial Fibrillation and Arterial Hypertension, run by Samara Regional Cardiology Dispensary at 1 site in Russia.
Trial summary
The Clinical Decision Support Systems (CDSS) based on real clinical data and its own algorithms can help to make the right choice according to guidelines. The goal of the INTELLECT II study is to investigate treatment adherence to guidelines/science-based medicine and its impact on patient outcomes into two groups of… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atrial Fibrillation, Arterial Hypertension
- What is being tested?
- CDSS ("MedicBK")
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteRussia
- Study dates
- 17 May 2022to 22 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Patients diagnosed with nonvalvular atrial fibrillation and hypertension and indications for therapy according to European guidelines.
Who cannot join
- Inability to adhere to study procedures
- Severe heart-valve disorder
- Stroke within 14 days or severe stroke within 6 months before screening
- Active bleedings
- Thyroid dysfunction
- Pregnancy
- Secondary hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active (CDSS) Control Blinded Multicenter, Cluster-randomized Trial of the Adherence to Clinical Practice Guidelines Using the Clinical Decision Support System in Patients With Hypertension and Atrial Fibrillation (INTELLECT II Trial)
The Clinical Decision Support Systems (CDSS) based on real clinical data and its own algorithms can help to make the right choice according to guidelines. The goal of the INTELLECT II study is to investigate treatment adherence to guidelines/science-based medicine and its impact on patient outcomes into two groups of doctors, clinical centers with standard care of treatment (control), and clinical centers using CDSS (active).
Read the detailed description
Hypertension and atrial fibrillation are 2 important public health priorities. There is a gap between evidence-based best management and actual clinical practice. To decrease this gap, clinical practice guidelines (CPGs), based on available evidence are employed. Clinical decision support system ("MedicBK") is a computer-based program that analyzes published evidence and provides prompts and reminders to assist health care providers in implementing clinical guidelines and science-based medicine at the point of care. The INTELLECT II trial is designed as a multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment. Approximately 10 centers from Russia will be enrolled. Centers managing patients with symptomatic atrial fibrillation and/or hypertension will be randomized to either patient management with aid of CDSS ("MedicBK") or standard care.
- Conditions
- Atrial Fibrillation, Arterial Hypertension
- Being tested
- CDSS ("MedicBK")
- Keywords
- clinical practice guidelines, Clinical Decision Support Systems, adherence to guidelines, evidence-based medicine
- Medical subject headings
- Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDSS ("MedicBK")Other
Clinical decision support system ("MedicBK") is a computer-based program that analyzes published evidence and provides prompts and reminders to assist health care providers in implementing clinical guidelines and science-based medicine at the point of care.
| Study group | Role | What they receive |
|---|---|---|
| CDSS | Active comparator | patient management with aid of CDSS Receives: Other: CDSS ("MedicBK") |
| standart care | No intervention | patient management with standard care according to guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with AF/hypertension clinical practice guidelines
number of patients treated in accordance with current ESC clinical guidelines for management atrial fibrillation evaluated by independent professionals compared with Clinical decision support system MedicBK
Measured: 1 month
Secondary outcomes (3)
Total cardiovascular events
total stroke or systemic embolism, total coronary heart disease, major bleeding, recurrence of atrial fibrillation, hospitalization or death from congestive heart failure and other significant vascular deaths
Measured: 6 months
Total mortality
death from all causes
Measured: 6 months
total number of non-planing visits and hospitalization
non-planing hospitalizations, non-planning visits, urgent visits
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start17 May 2022
- Primary completion24 Dec 2022
- Study completion22 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samara Regional Cardiology Dispensary
- Sponsor type
- University, hospital or other
- Collaborators
- Medicbook LLC
- Responsible party
- Principal investigator, Prof. Dmitry Duplyakov FESC, Samara Regional Cardiology Dispensary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367141
- Sponsor's protocol ID
- SamaraRCD
- Acronym
- INTELLECTII
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2022
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duplyakov D.V., Shebonkina D.A., Uranov A.E., Mikheenko I.L., Astrakova K.S., Gartung A.A., Adonina E.V., Tukhbatova A.A., Kuzmin V.P., Fedorova G.A., Gabidullova D.A., Skuratova M.A., Shechovtsova T.A., Losik D.V. Optimizing compliance with clinical guidelines using a clinical decision support system in patients with hypertension and atrial fibrillation in real-world practice: a cluster-randomized comparative study INTELLECT-2. Russian Journal of Cardiology. 2025;30(12):6365. (In Russ.) https://doi.org/10.15829/1560-4071-2025-6365. EDN: OKIRDC
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active (CDSS) Control Blinded Multicenter, Cluster-randomized Trial of the Adherence to Clinical Practice Guidelines Using the Clinical Decision Support System in Patients With Hypertension and Atrial Fibrillation (INTELLECT II Trial)
- ClinicalTrials.gov ID
- NCT05367141
- Acronym / sponsor ID
- INTELLECTII / SamaraRCD
- Conditions
- Atrial Fibrillation, Arterial Hypertension
- Keywords
- clinical practice guidelines, Clinical Decision Support Systems, adherence to guidelines, evidence-based medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Samara Regional Cardiology DispensaryUniversity, hospital or other
- Collaborators
- Medicbook LLC
- Study start
- 17 May 2022 (actual)
- Primary completion
- 24 Dec 2022 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 10 May 2022 (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.
The Clinical Decision Support Systems (CDSS) based on real clinical data and its own algorithms can help to make the right choice according to guidelines. The goal of the INTELLECT II study is to investigate treatment adherence to guidelines/science-based medicine and its impact on patient outcomes into two groups of doctors, clinical centers with standard care of treatment (control), and clinical centers using CDSS (active).
Detailed description
Hypertension and atrial fibrillation are 2 important public health priorities. There is a gap between evidence-based best management and actual clinical practice. To decrease this gap, clinical practice guidelines (CPGs), based on available evidence are employed. Clinical decision support system ("MedicBK") is a computer-based program that analyzes published evidence and provides prompts and reminders to assist health care providers in implementing clinical guidelines and science-based medicine at the point of care. The INTELLECT II trial is designed as a multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment. Approximately 10 centers from Russia will be enrolled. Centers managing patients with symptomatic atrial fibrillation and/or hypertension will be randomized to either patient management with aid of CDSS ("MedicBK") or standard care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment.
| Arm | Type | Receives |
|---|---|---|
| CDSS | Active comparator | Other: CDSS ("MedicBK")patient management with aid of CDSS |
| standart care | No intervention | –patient management with standard care according to guidelines |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years old
- Patients diagnosed with nonvalvular atrial fibrillation and hypertension and indications for therapy according to European guidelines.
Key exclusion criteria (7 listed)
- Inability to adhere to study procedures
- Severe heart-valve disorder
- Stroke within 14 days or severe stroke within 6 months before screening
- Active bleedings
- Thyroid dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDSS ("MedicBK")Clinical decision support system ("MedicBK") is a computer-based program that analyzes published evidence and provides prompts and reminders to assist health care providers in implementing clinical guidelines and science-based medicine at the point of care. | Other | CDSS |
Primary outcome
Compliance with AF/hypertension clinical practice guidelines
Time frame: 1 month
number of patients treated in accordance with current ESC clinical guidelines for management atrial fibrillation evaluated by independent professionals compared with Clinical decision support system MedicBK
3 secondary outcomes
Total cardiovascular events
Time frame: 6 months
Total mortality
Time frame: 6 months
total number of non-planing visits and hospitalization
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Results publicationDuplyakov D.V., Shebonkina D.A., Uranov A.E., Mikheenko I.L., Astrakova K.S., Gartung A.A., Adonina E.V., Tukhbatova A.A., Kuzmin V.P., Fedorova G.A., Gabidullova D.A., Skuratova M.A., Shechovtsova T.A., Losik D.V. Optimizing compliance with clinical guidelines using a clinical decision support system in patients with hypertension and atrial fibrillation in real-world practice: a cluster-randomized comparative study INTELLECT-2. Russian Journal of Cardiology. 2025;30(12):6365. (In Russ.) https://doi.org/10.15829/1560-4071-2025-6365. EDN: OKIRDC
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruitingPhase 4
A Comparison of Beta-blockers and Calcium Channel Blockers in Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Not yet recruiting
Dual-Energy Lattice-Tip Assisted Marshall-Plan Strategy in Redo Persistent Atrial Fibrillation Ablation
Atrial Fibrillation (AF)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDSS ("MedicBK") in people with Atrial Fibrillation and Arterial Hypertension, run by Samara Regional Cardiology Dispensary 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 2 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compliance with AF/hypertension clinical practice guidelines (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05367141, which also lists 1 linked publication.
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 2 Feb 2026.