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Antihypertensive Therapy in Patients With Comorbidities

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ClinicalTrials.gov Identifier: NCT04791046
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : March 11, 2021
Sponsor:
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
Information provided by (Responsible Party):
Evgeny Pokushalov, Center of Personalized Medicine, Pirogova

Study Description
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Brief Summary:
A retrospective analysis

Condition or disease Intervention/treatment
Adherence to Personalized EBM Antihypertensive Drug Prescriptions for Patients With Hypertension and Comorbidities in Everyday Clinical Practice Drug: antihypertensive therapy

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
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Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Personalized Evidence-based Medicine Improves Outcomes of Antihypertensive Therapy in Patients With Comorbidities
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
By CDSS (MedicBK) Analysis Drug: antihypertensive therapy
Personalized evidence-based antihypertensive therapy in patients with comorbidities
General practice Drug: antihypertensive therapy
Personalized evidence-based antihypertensive therapy in patients with comorbidities


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 3-year FU outcomes [ Time Frame: 3-year ]
    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.

  2. Quantify the performance of the CDSS (MedicBK) algorithm [ Time Frame: 3-year ]
    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

  3. Predictors [ Time Frame: 3-year ]
    Predictors of guideline-based and personalized EBM adherence


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with hypertension and comorbidities
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

No

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04791046


Contacts
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Contact: Evgeny Pokushalov, Prof. MD PhD 89139254858 e.pokushalov@gmail.com
Contact: Svetlana Kozlova, MD +79213360508 senpolia@yandex.ru

Locations
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Russian Federation
Evgeny Pokushalov Recruiting
Novosibirsk, Russian Federation, 630090
Contact: Evgeny Pokushalov, Prof. MD PhD    89139254858    e.pokushalov@gmail.com   
Sponsors and Collaborators
Center of Personalized Medicine, Pirogova
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
Investigators
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Principal Investigator: Evgeny Pokushalov, Prof. MD PhD Center for New Medical Technologies, Novosibirsk, Russia
More Information
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Responsible Party: Evgeny Pokushalov, Director for research and development, Center of Personalized Medicine, Pirogova
ClinicalTrials.gov Identifier: NCT04791046    
Other Study ID Numbers: 20210308
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents