Adherence to Personalized EBM Antihypertensive Drug Prescriptions for Patients With Hypertension and Comorbidities in Everyday Clinical PracticeNCT04791046
Antihypertensive Therapy in Patients With Comorbidities
An observational study of Adherence to Personalized EBM Antihypertensive Drug Prescriptions for Patients With Hypertension and Comorbidities in Everyday Clinical Practice, run by Center of Personalized Medicine, Pirogova at 1 site in Russia.
Trial summary
A retrospective analysis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adherence to Personalized EBM Antihypertensive Drug Prescriptions for Patients With Hypertension and Comorbidities in Everyday Clinical Practice
- What is being tested?
- antihypertensive therapy
- How many people
- 100,000 participants
- Where
- 1 siteRussia
- Study dates
- 1 Feb 2021to 30 Mar 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with hypertension and comorbidities
Who may be able to join
- patients who were first diagnosed with hypertension, attended the hospital as an outpatient due to hypertension, and received their antihypertensive prescription as an outpatient. To be eligible for inclusion, patients had to have comorbidities and outpatient visits or hospitalizations (for any indication) during the 3-years.
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Evgeny Pokushalov
Novosibirsk, 630090
Evgeny Pokushalov, Prof. MD PhD, 89139254858, e.pokushalov@gmail.com
About this study
Official title: Personalized Evidence-based Medicine Improves Outcomes of Antihypertensive Therapy in Patients With Comorbidities
A retrospective analysis
Read the detailed description
This retrospective study will be performed using all-Russian nationwide database of anonymized medical health claims and administrative data. The database holds information on diagnoses, patient data, medications, results of examinations, laboratory values, and genomic information, visits, follow up and outcomes. Participating health care organizations include a mix of hospital, primary care, and specialty treatment providers spanning a wide range of geographies, age groups, and income levels.
This study will analyze of outcomes according to comorbidity and antihypertensive drug prescriptions. The study will include patients who were first diagnosed with hypertension, attended the hospital as an outpatient due to hypertension, and received their antihypertensive prescription as an outpatient. To be eligible for inclusion, patients must have had comorbidities and outpatient visits or hospitalizations (for any indication) during the 3-years. The study will focused on comorbidities for choice of antihypertensive drug therapy: diabetes mellitus, dyslipidemia, gout/hyperuricemia, heart diseases, cerebrovascular diseases, and renal diseases.
We going to analyze the EMR of patients who had hypertension and comorbidities by CDSS (MedicBK) utilizing a core laboratory.
- Being tested
- antihypertensive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antihypertensive therapyDrug
Personalized evidence-based antihypertensive therapy in patients with comorbidities
| Study group | Role | What they receive |
|---|---|---|
| By CDSS (MedicBK) Analysis | Not described Receives: Drug: antihypertensive therapy | |
| General practice | Not described Receives: Drug: antihypertensive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of personalized evidence-based medicine recommendations
The percentage of personalized EBM recommendations acted on by clinicians for antihypertensive therapy in patients with comorbidities. All discrepancies between routine and CDSS-recommended treatment resulting in frame of guideline-based therapy and personalized EBM therapy will be adjudicated by core laboratory.
Measured: 3-year
Secondary outcomes (3)
3-year FU outcomes
Outcomes for stroke, coronary heart disease, heart failure, cardiovascular death, all cause death and the composite endpoints in relation to whether they were personalized EBM treatment or general practice.
Measured: 3-year
Quantify the performance of the CDSS (MedicBK) algorithm
Quantify the performance of the CDSS (MedicBK) algorithm for presents treatment suggestions in frame of guideline-based therapy and personalized EBM therapy: the sensitivity, specificity, NPV, and PPV
Measured: 3-year
Predictors
Predictors of guideline-based and personalized EBM adherence
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Feb 2021
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence to Personalized EBM Antihypertensive Drug Prescriptions for Patients With Hypertension and Comorbidities in Everyday Clinical PracticeStudies 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
- Retrospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center of Personalized Medicine, Pirogova
- Sponsor type
- University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia, I.M. Sechenov First Moscow State Medical University, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health, University of Rochester
- Responsible party
- Principal investigator, Evgeny Pokushalov, Center of Personalized Medicine, Pirogova
- Investigators
- Evgeny Pokushalov, Prof. MD PhD, Principal investigator, Center for New Medical Technologies, Novosibirsk, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791046
- Sponsor's protocol ID
- 20210308
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 11 Mar 2021
- 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 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Evidence-based Medicine Improves Outcomes of Antihypertensive Therapy in Patients With Comorbidities
- ClinicalTrials.gov ID
- NCT04791046
- Acronym / sponsor ID
- 20210308
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Center of Personalized Medicine, PirogovaUniversity, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia, I.M. Sechenov First Moscow State Medical University, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health, University of Rochester
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 10 Mar 2021 (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.
A retrospective analysis
Detailed description
This retrospective study will be performed using all-Russian nationwide database of anonymized medical health claims and administrative data. The database holds information on diagnoses, patient data, medications, results of examinations, laboratory values, and genomic information, visits, follow up and outcomes. Participating health care organizations include a mix of hospital, primary care, and specialty treatment providers spanning a wide range of geographies, age groups, and income levels.
This study will analyze of outcomes according to comorbidity and antihypertensive drug prescriptions. The study will include patients who were first diagnosed with hypertension, attended the hospital as an outpatient due to hypertension, and received their antihypertensive prescription as an outpatient. To be eligible for inclusion, patients must have had comorbidities and outpatient visits or hospitalizations (for any indication) during the 3-years. The study will focused on comorbidities for choice of antihypertensive drug therapy: diabetes mellitus, dyslipidemia, gout/hyperuricemia, heart diseases, cerebrovascular diseases, and renal diseases.
We going to analyze the EMR of patients who had hypertension and comorbidities by CDSS (MedicBK) utilizing a core laboratory.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| By CDSS (MedicBK) Analysis | – | Drug: antihypertensive therapy |
| General practice | – | Drug: antihypertensive therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with hypertension and comorbidities
Key inclusion criteria (1 listed)
- patients who were first diagnosed with hypertension, attended the hospital as an outpatient due to hypertension, and received their antihypertensive prescription as an outpatient. To be eligible for inclusion, patients had to have comorbidities and outpatient visits or hospitalizations (for any indication) during the 3-years.
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| antihypertensive therapyPersonalized evidence-based antihypertensive therapy in patients with comorbidities | Drug | By CDSS (MedicBK) Analysis, General practice |
Primary outcome
The percentage of personalized evidence-based medicine recommendations
Time frame: 3-year
The percentage of personalized EBM recommendations acted on by clinicians for antihypertensive therapy in patients with comorbidities. All discrepancies between routine and CDSS-recommended treatment resulting in frame of guideline-based therapy and personalized EBM therapy will be adjudicated by core laboratory.
3 secondary outcomes
3-year FU outcomes
Time frame: 3-year
Quantify the performance of the CDSS (MedicBK) algorithm
Time frame: 3-year
Predictors
Time frame: 3-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: No
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.
Evgeny Pokushalov, Prof. MD PhD principal investigator
Center for New Medical Technologies, Novosibirsk, Russia
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 Adherence to Personalized EBM Antihypertensive Drug Prescriptions for Patients With Hypertension and Comorbidities in Everyday Clinical Practice, run by Center of Personalized Medicine, Pirogova 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evgeny Pokushalov, Prof. MD PhD (89139254858, e.pokushalov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of personalized evidence-based medicine recommendations (time frame: 3-year). 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 11 Mar 2021.