"Escape" Phenomenon of the Antihypertensive Therapy Efficacy (ESCAPE)

June 28, 2022 updated by: Mikhailova Oksana, Federal State Budgetary Institution NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED AFTER ACADE

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Men and women aged 18-90 years with arterial hypertension grade 1-3, stage I-II and initially achieved target BP levels while taking 2-3-component AHT.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
"Escape" Phenomenon of the Antihypertensive Therapy Efficacy
Men and women aged 18-90 years with arterial hypertension grade 1-3, stage I-II and initially achieved target BP levels while taking 2-3-component AHT.
Device: Ambulatory blood pressure measurement device
Assessment of the 24-h blood pressure profile
Other Names:
  • BpLab
Device: Sphygmocor
Assessment of the arterial stiffness
Device: VaSera-VS
Assessment of the arterial stiffness
Device: Somnocheck
Assessment of the sleep breath disturbances

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of BP increasing higher the target level when taking the same therapy
Time Frame: 1-6 months
Assessment of attenuation of efficacy of previously adequate antihypertensive therapy by using different BP measurement methods
1-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease course: assessment of major CVE and death occurrence
Time Frame: 10 years
Assessment of the disease course depending on the characteristics of 3-6th months of observation
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2015

Primary Completion (Actual)

December 30, 2016

Study Completion (Anticipated)

December 30, 2025

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

June 28, 2022

First Posted (Actual)

June 29, 2022

Study Record Updates

Last Update Posted (Actual)

June 29, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 115061870017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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