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

Resistant Arterial Hypertension Clinical Trial

— SAGA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05899920
• Other study ID #: SAGA-01
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Ryazan State Medical University
• Contact: Sergey V Seleznev, MD, PhD
• Phone: +79105749526
• Email: sv.seleznev[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 31, 2024
• Est. primary completion date: November 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Resistant Arterial Hypertension

Intervention

Diagnostic Test:
• Blood samples will be taken for pharmacokinetics and pharmacogenetics
To assess antihypertensive drugs concentration (lisinopril, valsartan, amlodipine, indapamide

Locations

Country	Name	City	State
Russian Federation	Ryzan State Medical University	Ryazan

Sponsors (1)

Lead Sponsor	Collaborator
Ryazan State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Concentration of lisinopril, valsartan, amlodipin, indapamide, metoprolol	Number of Participants with antihypertensive drug concentraion below the limit of quantitative determination	day 1