Skip to content

Antihypertensive Therapy in Patients With Comorbidities

Personalized Evidence-based Medicine Improves Outcomes of Antihypertensive Therapy in Patients With Comorbidities

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04791046
Enrollment
100000
Registered
2021-03-10
Start date
2021-02-01
Completion date
2021-03-30
Last updated
2021-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence to Personalized EBM Antihypertensive Drug Prescriptions for Patients With Hypertension and Comorbidities in Everyday Clinical Practice

Brief summary

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.

Interventions

Personalized evidence-based antihypertensive therapy in patients with comorbidities

Sponsors

Center for New Medical Technologies, Novosibirsk, Russia
CollaboratorOTHER
I.M. Sechenov First Moscow State Medical University
CollaboratorOTHER
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
CollaboratorOTHER
University of Rochester
CollaboratorOTHER
Center of Personalized Medicine, Pirogova
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The percentage of personalized evidence-based medicine recommendations3-yearThe 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

MeasureTime frameDescription
3-year FU outcomes3-yearOutcomes 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.
Quantify the performance of the CDSS (MedicBK) algorithm3-yearQuantify 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
Predictors3-yearPredictors of guideline-based and personalized EBM adherence

Countries

Russia

Contacts

Primary ContactEvgeny Pokushalov, Prof. MD PhD
e.pokushalov@gmail.com89139254858
Backup ContactSvetlana Kozlova, MD
senpolia@yandex.ru+79213360508

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026