Arterial HypertensionESCAPENCT05436730
"Escape" Phenomenon of the Antihypertensive Therapy Efficacy
An observational study of Arterial Hypertension, run by Federal State Budgetary Institution NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED AFTER ACADE at 1 site in Russia.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arterial Hypertension
- What is being tested?
- Ambulatory blood pressure measurement device, Sphygmocor and VaSera-VS
- Type of treatment
- Medical device
- How many people
- 165 participants
- Where
- 1 siteRussia
- Study dates
- 29 Sep 2015to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Secondary AH
- Resistant AH,
- AH III stage,
- PAP- therapy,
- type 2 diabetes mellitus,
- pregnancy
- history of low adherence to treatment
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Arterial Hypertension
- Being tested
- Ambulatory blood pressure measurement device, Sphygmocor, VaSera-VS, Somnocheck
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory blood pressure measurement deviceDevice
Also called BpLab
Assessment of the 24-h blood pressure profile
SphygmocorDevice
Assessment of the arterial stiffness
VaSera-VSDevice
Assessment of the arterial stiffness
SomnocheckDevice
Assessment of the sleep breath disturbances
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: Device: Ambulatory blood pressure measurement device; Device: Sphygmocor; Device: VaSera-VS; Device: Somnocheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-6 months
Secondary outcomes (1)
Disease course: assessment of major CVE and death occurrence
Assessment of the disease course depending on the characteristics of 3-6th months of observation
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start29 Sep 2015
- Primary completion30 Dec 2016
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED AFTER ACADE
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mikhailova Oksana, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436730
- Sponsor's protocol ID
- 115061870017
- Acronym
- ESCAPE
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05436730
- Acronym / sponsor ID
- ESCAPE / 115061870017
- Conditions
- Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Federal State Budgetary Institution NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED AFTER ACADEOther government
- Study start
- 29 Sep 2015 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "Escape" Phenomenon of the Antihypertensive Therapy Efficacy | – | Device: Ambulatory blood pressure measurement device, Device: Sphygmocor, Device: VaSera-VS, Device: SomnocheckMen 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Secondary AH
- Resistant AH,
- AH III stage,
- PAP- therapy,
- type 2 diabetes mellitus,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory blood pressure measurement deviceAlso: BpLabAssessment of the 24-h blood pressure profile | Device | "Escape" Phenomenon of the Antihypertensive Therapy Efficacy |
| SphygmocorAssessment of the arterial stiffness | Device | "Escape" Phenomenon of the Antihypertensive Therapy Efficacy |
| VaSera-VSAssessment of the arterial stiffness | Device | "Escape" Phenomenon of the Antihypertensive Therapy Efficacy |
| SomnocheckAssessment of the sleep breath disturbances | Device | "Escape" Phenomenon of the Antihypertensive Therapy Efficacy |
Primary outcome
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 secondary outcome
Disease course: assessment of major CVE and death occurrence
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Hypertension, run by Federal State Budgetary Institution NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED AFTER ACADE at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of BP increasing higher the target level when taking the same therapy (time frame: 1-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.