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ESCAPE: "Escape" Phenomenon of the Antihypertensive Therapy Efficacy

Sponsor
Federal State Budgetary Institution NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED AFTER ACADE (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05436730
Collaborator
(none)
165
Enrollment
1
Location
123
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ambulatory blood pressure measurement device
  • Device: Sphygmocor
  • Device: VaSera-VS
  • Device: Somnocheck

Study Design

Study Type:
Observational
Actual Enrollment :
165 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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.
Actual Study Start Date :
Sep 29, 2015
Actual Primary Completion Date :
Dec 30, 2016
Anticipated Study Completion Date :
Dec 30, 2025

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of BP increasing higher the target level when taking the same therapy [1-6 months]

      Assessment of attenuation of efficacy of previously adequate antihypertensive therapy by using different BP measurement methods

    Secondary Outcome Measures

    1. Disease course: assessment of major CVE and death occurrence [10 years]

      Assessment of the disease course depending on the characteristics of 3-6th months of observation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oksana Mikhailova Moscow Russian Federation

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mikhailova Oksana, Dr., clinical reseacher, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
    ClinicalTrials.gov Identifier:
    NCT05436730
    Other Study ID Numbers:
    • 115061870017
    First Posted:
    Jun 29, 2022
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension

    Study Results

    No Results Posted as of Jun 29, 2022