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

NCT05899920 | Recruiting

• 1 other identifier: SAGA-01
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to assess the concentration of antihypertensive drugs in the blood plasma in patients with controlled and uncontrolled arterial hypertension. 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.

Conditions

Resistant Arterial Hypertension

Keywords

antihypertensive drugs; concentration; HPLC MS/MS

Outcome Measures

Primary Outcomes (1)

• Plasma Concentration of lisinopril, valsartan, amlodipin, indapamide, metoprolol

  Number of Participants with antihypertensive drug concentraion below the limit of quantitative determination

  day 1

Study Arms (2)

Controlled arterial hypertension

ACTIVE COMPARATOR

Controlled arterial hypertension according the results of 24-hour blood pressure monitoring. Blood samples will be taken for pharmacokinetics and pharmacogenetics

Diagnostic Test: Blood samples will be taken for pharmacokinetics and pharmacogenetics

Uncontrolled arterial hypertension

EXPERIMENTAL

Uncontrolled arterial hypertension according the results of 24-hour blood pressure monitoring. Blood samples will be taken for pharmacokinetics and pharmacogenetics

Diagnostic Test: Blood samples will be taken for pharmacokinetics and pharmacogenetics

Interventions

Blood samples will be taken for pharmacokinetics and pharmacogenetics DIAGNOSTIC_TEST

To assess antihypertensive drugs concentration (lisinopril, valsartan, amlodipine, indapamide

Controlled arterial hypertension; Uncontrolled arterial hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient's connection with the organization or conducting of the study;
• Pregnancy.

Sponsors & Collaborators

• Ryazan State Medical University: lead

Study Sites (1)

Ryzan State Medical University

Ryazan, 390026, Russia

RECRUITING

MeSH Terms

Interventions

Pharmacokinetics; Pharmacogenomic Testing

Intervention Hierarchy (Ancestors)

Metabolism; Pharmacological and Toxicological Phenomena; Physiological Phenomena; Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Central Study Contacts

Sergey V Seleznev, MD, PhD

CONTACT

+79105749526; sv.seleznev@gmail.com

Alexey V Shchulkin, MD, PhD

CONTACT

+79209520024; alekseyshulkin@rambler.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: June 12, 2023
• Study Start: March 11, 2022
• Primary Completion: November 11, 2024
• Study Completion: December 31, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

RU (1)