NCT05436730

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2016

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

1.3 years

First QC Date

June 22, 2022

Last Update Submit

June 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Disease course: assessment of major CVE and death occurrence

    10 years

Study Arms (1)

"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 deviceDevice: SphygmocorDevice: VaSera-VSDevice: Somnocheck

Interventions

Assessment of the 24-h blood pressure profile

Also known as: BpLab
"Escape" Phenomenon of the Antihypertensive Therapy Efficacy

Assessment of the arterial stiffness

"Escape" Phenomenon of the Antihypertensive Therapy Efficacy
VaSera-VSDEVICE

Assessment of the arterial stiffness

"Escape" Phenomenon of the Antihypertensive Therapy Efficacy

Assessment of the sleep breath disturbances

"Escape" Phenomenon of the Antihypertensive Therapy Efficacy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Secondary AH
  • Resistant AH,
  • AH III stage,
  • PAP- therapy,
  • type 2 diabetes mellitus,
  • pregnancy
  • history of low adherence to treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oksana Mikhailova

Moscow, Russia

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr., clinical reseacher

Study Record Dates

First Submitted

June 22, 2022

First Posted

June 29, 2022

Study Start

September 29, 2015

Primary Completion

December 30, 2016

Study Completion

December 30, 2025

Last Updated

June 29, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations