Antihypertensive Therapy in Patients With Comorbidities

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

A retrospective analysis

Study Overview

• Status: Recruiting
• Conditions: Adherence to Personalized EBM Antihypertensive Drug Prescriptions for Patients With Hypertension and Comorbidities in Everyday Clinical Practice
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 100000

Contacts and Locations

• Study Contact: Name: Svetlana Kozlova, MD; Phone Number: +79213360508; Email: senpolia@yandex.ru

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630090
    • Recruiting
    • Evgeny Pokushalov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with hypertension and comorbidities

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	3-year
Predictors	Predictors of guideline-based and personalized EBM adherence	3-year

Collaborators and Investigators

• Sponsor: Center of Personalized Medicine, Pirogova
• Collaborators: University of Rochester; 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; Center for New Medical Technologies, Novosibirsk, Russia

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ANTICIPATED): March 30, 2021
• Study Completion (ANTICIPATED): March 30, 2021

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (ACTUAL): March 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Antihypertensive Agents
• Other Study ID Numbers: 20210308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No