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

Primary Purpose

Resistant Arterial Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Blood samples will be taken for pharmacokinetics and pharmacogenetics
Sponsored by
Ryazan State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Resistant Arterial Hypertension focused on measuring antihypertensive drugs, concentration, HPLC MS/MS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ryzan State Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Controlled arterial hypertension

Uncontrolled arterial hypertension

Arm Description

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

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

Outcomes

Primary Outcome Measures

low level of antihypertensive drug
antihypertensive drug concentraion below the limit of quantitative determination

Secondary Outcome Measures

Full Information

First Posted
May 2, 2023
Last Updated
June 1, 2023
Sponsor
Ryazan State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05899920
Brief Title
Clinical One-stage Controlled Study of reSistant Arterial Hypertension for the desiGning of a personAlized Approach to Therapy
Acronym
SAGA
Official Title
Clinical One-stage Controlled Study of reSistant Arterial Hypertension for the desiGning of a personAlized Approach to Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
March 11, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ryazan State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resistant Arterial Hypertension
Keywords
antihypertensive drugs, concentration, HPLC MS/MS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Controlled arterial hypertension
Arm Type
Active Comparator
Arm Description
Controlled arterial hypertension according the results of 24-hour blood pressure monitoring. Blood samples will be taken for pharmacokinetics and pharmacogenetics
Arm Title
Uncontrolled arterial hypertension
Arm Type
Experimental
Arm Description
Uncontrolled arterial hypertension according the results of 24-hour blood pressure monitoring. Blood samples will be taken for pharmacokinetics and pharmacogenetics
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood samples will be taken for pharmacokinetics and pharmacogenetics
Intervention Description
To assess antihypertensive drugs concentration (lisinopril, valsartan, amlodipine, indapamide
Primary Outcome Measure Information:
Title
low level of antihypertensive drug
Description
antihypertensive drug concentraion below the limit of quantitative determination
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergey V Seleznev, MD, PhD
Phone
+79105749526
Email
sv.seleznev@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alexey V Shchulkin, MD, PhD
Phone
+79209520024
Email
alekseyshulkin@rambler.ru
Facility Information:
Facility Name
Ryzan State Medical University
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey V Seleznev, MD, PhD
Phone
+79105749526
Email
sv.seleznev@gmail.com
First Name & Middle Initial & Last Name & Degree
Alexey V Shchulkin, MD, PhD
Phone
+79209520024
Email
alekseyshulkin@rambler.ru
First Name & Middle Initial & Last Name & Degree
Sergey S Yakushin, MD, PhD
First Name & Middle Initial & Last Name & Degree
Pavel Yu Mylnikov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Elena N Yakusheva, MD, PhD
First Name & Middle Initial & Last Name & Degree
Natalia N Nikulina, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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