Clinical One-stage Controlled Study of reSistant Arterial Hypertension for the desiGning of a personAlized Approach to Therapy

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Methods: it is planned to include patients with arterial hypertension taking 3 antihypertensive drugs (indapanide, lisinopril or valsartan, amlodipine). Based on the results of 24-hour blood pressure monitoring, the patients will be randomized into two groups: The first group - the patients with controlled AH; The second group - the patients with uncontrolled AH. Venous blood was taken in both groups of the patients in the morning before and 2 hours after taking drugs to assess the concentration of lisinopril, amlodipine, valsartan and indapamide. Concentation of assesed antihypertensive drugs will be compared in both groups.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Signed informed consent form;

• An established diagnosis of AH based on the Clinical Guidelines Arterial hyperten-sion in adults, approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation, 2020;

• Mandatory patient compliance with recommendations for lifestyle modification in accordance with the Clinical Guidelines Arterial hypertension in adults, approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation, 2020 .

• Regular administration of any two antihypertensive drugs (lisinopril, amlodipine, valsartan) in combination with indapamide for a month, possibly in fixed combinations, in stable dosages;

• Fertile female patients must use proper methods of contraception throughout the study period.

Locations
Other Locations
Russian Federation
Ryzan State Medical University
RECRUITING
Ryazan
Contact Information
Primary
Sergey V Seleznev, MD, PhD
sv.seleznev@gmail.com
+79105749526
Backup
Alexey V Shchulkin, MD, PhD
alekseyshulkin@rambler.ru
+79209520024
Time Frame
Start Date: 2022-03-11
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 190
Treatments
Active_comparator: Controlled arterial hypertension
Controlled arterial hypertension according the results of 24-hour blood pressure monitoring.~Blood samples will be taken for pharmacokinetics and pharmacogenetics
Experimental: Uncontrolled arterial hypertension
Uncontrolled arterial hypertension according the results of 24-hour blood pressure monitoring.~Blood samples will be taken for pharmacokinetics and pharmacogenetics
Related Therapeutic Areas
Sponsors
Leads: Ryazan State Medical University

This content was sourced from clinicaltrials.gov