"Escape" Phenomenon of the Antihypertensive Therapy Efficacy

Arterial Hypertension Clinical Trial

— ESCAPE  

Official title:

The Role of Ambulatory Blood Pressure Characteristics, Features of the Structural and Functional Vascular Wall State, the Presence and Severity of Obstructive Sleep Apnea Syndrome in Predicting the "Escape" Phenomenon of the Antihypertensive Therapy Efficacy.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05436730
• Other study ID #: 115061870017
• Status: Active, not recruiting
• Start date: September 29, 2015
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2022
• Source: Federal State Budgetary Institution NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED AFTER ACADE
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A little attention is paid to the AHT efficacy escaping problem, which can be explained by the AHT correction simplicity and rapid achievement of the target BP level. Nevertheless, modern statistic data on the effective AH treatment described above let us assume that AHT correction is either totally absent or is untimely in case of the "escape" phenomenon development. This could be one of the main reasons for the high prevalence of ineffective AH treatment. The aim of this study is to determine AHT efficacy "escape" phenomenon timeline and its predictors in hypertensive patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 165
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Arterial hypertension (AH) grade 1-3, stage I-II

• High compliance during the follow-up period (= 85%)

• Initially achieved target office BP levels while taking 2-3-component AHT

Exclusion Criteria:

• Secondary AH

• Resistant AH,

• AH III stage,

• PAP- therapy,

• type 2 diabetes mellitus,

• pregnancy

• history of low adherence to treatment

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension

Intervention

Device:
• Ambulatory blood pressure measurement device
Assessment of the 24-h blood pressure profile
• Sphygmocor
Assessment of the arterial stiffness
• VaSera-VS
Assessment of the arterial stiffness
• Somnocheck
Assessment of the sleep breath disturbances

Locations

Country	Name	City	State
Russian Federation	Oksana Mikhailova	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Federal State Budgetary Institution NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED AFTER ACADE

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of BP increasing higher the target level when taking the same therapy	Assessment of attenuation of efficacy of previously adequate antihypertensive therapy by using different BP measurement methods	1-6 months
Secondary	Disease course: assessment of major CVE and death occurrence	Assessment of the disease course depending on the characteristics of 3-6th months of observation	10 years