Antihypertensive Therapy in Patients With Comorbidities

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04791046
• Other study ID #: 20210308
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: March 30, 2021

Study information

• Verified date: March 2021
• Source: Center of Personalized Medicine, Pirogova
• Contact: Evgeny Pokushalov, Prof. MD PhD
• Phone: 89139254858
• Email: e.pokushalov[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective analysis

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• antihypertensive therapy
Personalized evidence-based antihypertensive therapy in patients with comorbidities

Locations

Country	Name	City	State
Russian Federation	Evgeny Pokushalov	Novosibirsk

Sponsors (5)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Predictors	Predictors of guideline-based and personalized EBM adherence	3-year