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

Ryazan State Medical University

Status: Enrolling

Conditions: Resistant Arterial Hypertension

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05899920

SAGA-01

Details and patient eligibility

About

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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Controlled arterial hypertension

Active Comparator group

Description:

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

Treatment:

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

Uncontrolled arterial hypertension

Experimental group

Description:

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

Treatment:

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