Clinical trial NCT04791046: Antihypertensive Therapy in Patients With Comorbidities
Official title: Personalized Evidence-based Medicine Improves Outcomes of Antihypertensive Therapy in Patients With Comorbidities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adherence to Personalized EBM Antihypertensive Drug Prescriptions for Patients With Hypertension and Comorbidities in Everyday Clinical Practice
Lead sponsor: Center of Personalized Medicine, Pirogova
Sponsor class: OTHER
Collaborators: name: Center for New Medical Technologies, Novosibirsk, Russia
name: I.M. Sechenov First Moscow State Medical University
name: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
name: University of Rochester
First posted: 2021-03-10
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with hypertension and comorbidities

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.

Eligibility 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

Primary outcomes:
measure: The percentage of personalized evidence-based medicine recommendations
timeFrame: 3-year
Secondary outcomes:
measure: 3-year FU outcomes
timeFrame: 3-year
measure: Quantify the performance of the CDSS (MedicBK) algorithm
timeFrame: 3-year
measure: Predictors
timeFrame: 3-year
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Evgeny Pokushalov
Study officials:
affiliation: Center for New Medical Technologies, Novosibirsk, Russia
name: Evgeny Pokushalov, Prof. MD PhD
role: PRINCIPAL_INVESTIGATOR
References: