HypertensionGYMNsNCT03578848
Guiding Hypertension Management Using Different Blood Pressure Monitoring Strategies
A study testing uAOBP, Home BP and CBP in people with Hypertension, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Patients with uncontrolled or newly diagnosed hypertension will be randomized to have hypertension management decisions made on the basis of the unattended automated blood pressure (uAOBP) , home BP, and central BP monitoring. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Hypertension
- What is being tested?
- uAOBP, Home BP and CBP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jun 2018to 1 Mar 2020
- Phase
- Interventional
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 to 90 years of age
- nonpregnant
- receiving antihypertensive therapy for uncomplicated essential hypertension and taking ≥1 but ≤ 2 types antihypertensive drugs (to rule out complicated or resistant hypertension) or hypertension newly diagnosed by uAOBP (uAOBP >130 mmHg at screening visit)
Who cannot join
- Poor adherence to medication
- unable to conduct self-measurement blood pressure
- history of polycystic kidney disease
- congestive heart failure (a recent assessment of left ventricular ejection fraction < 40% prior to screening visit)
- chronic kidney disease with estimated glomerular filtration rate < 30 mL/min/1.73m2 (MDRD) at screening visit
- a recent document of severely abnormal left ventricular mass index (>59 g/m2.7 in women and >64 g/m2.7 in men) prior to screening visit
Show all 12Show fewer
- secondary causes of hypertension
- uncontrolled hypertension (uAOBP >180/100 mm Hg at screening visit)
- history of severe aortic valve disease
- history of upper limb obstructive atherosclerosis
- history of atrial fibrillation
- BP Differences more than 5 mmHg between both arms at screening visit
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 111
Hao-Min Cheng, M.D., Ph.D., (886)-2-28757302 ext. 307, hmcheng@vghtpe.gov.tw
About this study
Official title: A Randomized Controlled Trial Comparing Unattended Automated Office Blood Pressure vs. Home Blood Pressure vs. Central Blood Pressure Monitoring for the Management of Hypertension
Patients with uncontrolled or newly diagnosed hypertension will be randomized to have hypertension management decisions made on the basis of the unattended automated blood pressure (uAOBP) , home BP, and central BP monitoring. This study evaluates the optimal guiding strategy for hypertension will help define which BP monitoring is the most effective strategy to guide the clinical management of hypertension.
Read the detailed description
The traditional BP used for clinical practice, the office BP, is usually measured in a busy and hurry clinical environment, and interfered by the well-known confounding whitecoat effect. As such, unattended automated office BP monitoring (uAOBP) has been proposed as an effective solution and further promoted by Canadian physicians.
Nonetheless, out-of-office BP, home BP and ambulatory BP, remains the methodology of recommendation for the detection of whitecoat effect, and its prognostic value has been demonstrated to be superior to the traditional office BP. Home BP monitoring, with its ability to detect morning and masked hypertension and a better tolerability than ambulatory BP monitoring for long-term use, can therefore be considered as a strategy of choice to replace office BP monitoring for guiding hypertension management.
Moreover, BP measurements in the peripheral arteries cannot serve as direct substitutes for their central counterparts because of the long-recognized differences of blood pressure (BP) waveforms and values between the central aorta and peripheral arterial system. Thus, if the decisions on medication adjustment are made solely based brachial BP, there could be a considerable risk of over- or undertreatment.
Considering that there are many better strategies for guiding hypertension management than traditional office BP, there is an apparent need for investigating their comparative effectiveness and safety in the management of hypertension. The investigators hypothesized that home BP may be non-inferior to AOBP and central BP-guided intervention in reducing ambulatory BP and designed the present randomized controlled trial.
- Conditions
- Hypertension
- Being tested
- uAOBP, Home BP, CBP
- Keywords
- blood pressure monitoring, sphygmomanometer
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uAOBPDevice
For the uAOBP and CBP, the measurements will be conducted in a quiet room without the presence of clinical personnel. Patients will be seated in a quiet room without talking and taken as an average of 3 measurements with an automated device (HEM-907, Omron Healthcare, Lake Forest, IL) that has been preset to wait 5 minutes before measurements. Simultaneously, the central BP will be measured in the other upper arm. (WatchBP Office Central; Microlife AG, Widnau, Switzerland). The determination of the right or left upper arm for uAOBP or central BP will be made in a random order by computer generated random codes before the enrollment.
Home BPDevice
As for the home BP measurements, a validated device (WatchBP Home; Microlife AG, Widnau, Switzerland) will be provided for all subjects allocated to the home BP arm to measure their BP at home. Subjects are requested to take BP in the morning (within 2 hours after awakening) and afternoon before meals for 7 consecutive days before the scheduled clinical visits. BP in the first day of the measurements will be discarded and an average of home BP (all BP reading and BP in the morning and in the afternoon) will be generated and provided for clinicians to guide their treatment.
CBPDevice
For the uAOBP and CBP, the measurements will be conducted in a quiet room without the presence of clinical personnel. Patients will be seated in a quiet room without talking and taken as an average of 3 measurements with an automated device (HEM-907, Omron Healthcare, Lake Forest, IL) that has been preset to wait 5 minutes before measurements. Simultaneously, the central BP will be measured in the other upper arm. (WatchBP Office Central; Microlife AG, Widnau, Switzerland). The determination of the right or left upper arm for uAOBP or central BP will be made in a random order by computer generated random codes before the enrollment.
| Study group | Role | What they receive |
|---|---|---|
| uAOBP & Home BP | Active comparator | On the scheduled visits, the uAOBP and Home BP will be measured before meeting doctors and provided for clinicians to adjust patients' medication according to practice guideline. Receives: Device: uAOBP; Device: Home BP |
| CBP & Home BP | Experimental | On the scheduled visits, the CBP and Home BP will be measured before meeting doctors and provided for clinicians to adjust patients' medication according to practice guideline. Receives: Device: Home BP; Device: CBP |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour mean ambulatory systolic blood pressure
The change of 24 hour mean ambulatory systolic blood pressure (SBP)
Measured: 3 months
Secondary outcomes (3)
24 hour mean ambulatory diastolic blood pressure
The change of 24 hour mean ambulatory diastolic blood pressure (DBP)
Measured: 3 months
left ventricular mass
decrease of left ventricular mass
Measured: 12 months
SBP and DBP
change of SBP/DBP measured by uAOBP monitoring, home BP monitoring, or central BP monitoring
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start6 Jun 2018
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- BP will be taken simultaneously from both upper arms by an oscillometric BP monitor. Subjects with SBP Differences between both arms more than 5 mmHg will be excluded. For the unattended automated BP (uAOBP) and central BP (CBP), the measurements will be conducted in a quiet room without the presence of clinical personnel. Simultaneously, the central BP will be measured in the other upper arm. The determination of the right or left upper arm for uAOBP or central BP will be made in a random order by computer generated random codes before the enrollment. As for the home BP measurements, a validated device will be provided for all subjects allocated to the home BP arm to measure their BP at home. Subjects are requested to take BP in the morning and afternoon before meals for 7 consecutive days before the scheduled clinical visits. BP in the first day of the measurements will be discarded and an average of home BP will be generated and provided for clinicians to guide their treatment.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hao-Min Cheng, M.D., Ph.D., Principal investigator, Taipei Veterans General Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578848
- Sponsor's protocol ID
- 2018-05-009A
- Acronym
- GYMNs
- Status last verified
- Sep 2018
- First submitted
- 4 Jun 2018
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cheng HM, Sung SH, Chen CH, Yu WC, Yang SM, Guo CY, Chuang SY, Chiang CE. Guiding Hypertension Management Using Different Blood Pressure Monitoring Strategies (GYMNs study): comparison of three different blood pressure measurement methods: study protocol for a randomized controlled trial. Trials. 2019 May 10;20(1):265. doi: 10.1186/s13063-019-3366-8.
PubMed 31077229
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Unattended Automated Office Blood Pressure vs. Home Blood Pressure vs. Central Blood Pressure Monitoring for the Management of Hypertension
- ClinicalTrials.gov ID
- NCT03578848
- Acronym / sponsor ID
- GYMNs / 2018-05-009A
- Conditions
- Hypertension
- Keywords
- blood pressure monitoring, sphygmomanometer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 6 Jul 2018 (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.
Patients with uncontrolled or newly diagnosed hypertension will be randomized to have hypertension management decisions made on the basis of the unattended automated blood pressure (uAOBP) , home BP, and central BP monitoring. This study evaluates the optimal guiding strategy for hypertension will help define which BP monitoring is the most effective strategy to guide the clinical management of hypertension.
Detailed description
The traditional BP used for clinical practice, the office BP, is usually measured in a busy and hurry clinical environment, and interfered by the well-known confounding whitecoat effect. As such, unattended automated office BP monitoring (uAOBP) has been proposed as an effective solution and further promoted by Canadian physicians.
Nonetheless, out-of-office BP, home BP and ambulatory BP, remains the methodology of recommendation for the detection of whitecoat effect, and its prognostic value has been demonstrated to be superior to the traditional office BP. Home BP monitoring, with its ability to detect morning and masked hypertension and a better tolerability than ambulatory BP monitoring for long-term use, can therefore be considered as a strategy of choice to replace office BP monitoring for guiding hypertension management.
Moreover, BP measurements in the peripheral arteries cannot serve as direct substitutes for their central counterparts because of the long-recognized differences of blood pressure (BP) waveforms and values between the central aorta and peripheral arterial system. Thus, if the decisions on medication adjustment are made solely based brachial BP, there could be a considerable risk of over- or undertreatment.
Considering that there are many better strategies for guiding hypertension management than traditional office BP, there is an apparent need for investigating their comparative effectiveness and safety in the management of hypertension. The investigators hypothesized that home BP may be non-inferior to AOBP and central BP-guided intervention in reducing ambulatory BP and designed the present randomized controlled trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- BP will be taken simultaneously from both upper arms by an oscillometric BP monitor. Subjects with SBP Differences between both arms more than 5 mmHg will be excluded. For the unattended automated BP (uAOBP) and central BP (CBP), the measurements will be conducted in a quiet room without the presence of clinical personnel. Simultaneously, the central BP will be measured in the other upper arm. The determination of the right or left upper arm for uAOBP or central BP will be made in a random order by computer generated random codes before the enrollment. As for the home BP measurements, a validated device will be provided for all subjects allocated to the home BP arm to measure their BP at home. Subjects are requested to take BP in the morning and afternoon before meals for 7 consecutive days before the scheduled clinical visits. BP in the first day of the measurements will be discarded and an average of home BP will be generated and provided for clinicians to guide their treatment.
| Arm | Type | Receives |
|---|---|---|
| uAOBP & Home BP | Active comparator | Device: uAOBP, Device: Home BPOn the scheduled visits, the uAOBP and Home BP will be measured before meeting doctors and provided for clinicians to adjust patients' medication according to practice guideline. |
| CBP & Home BP | Experimental | Device: Home BP, Device: CBPOn the scheduled visits, the CBP and Home BP will be measured before meeting doctors and provided for clinicians to adjust patients' medication according to practice guideline. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 to 90 years of age
- nonpregnant
- receiving antihypertensive therapy for uncomplicated essential hypertension and taking ≥1 but ≤ 2 types antihypertensive drugs (to rule out complicated or resistant hypertension) or hypertension newly diagnosed by uAOBP (uAOBP >130 mmHg at screening visit)
Key exclusion criteria (12 listed)
- Poor adherence to medication
- unable to conduct self-measurement blood pressure
- history of polycystic kidney disease
- congestive heart failure (a recent assessment of left ventricular ejection fraction < 40% prior to screening visit)
- chronic kidney disease with estimated glomerular filtration rate < 30 mL/min/1.73m2 (MDRD) at screening visit
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 |
|---|---|---|
| uAOBPFor the uAOBP and CBP, the measurements will be conducted in a quiet room without the presence of clinical personnel. Patients will be seated in a quiet room without talking and taken as an average of 3 measurements with an automated device (HEM-907, Omron Healthcare, Lake Forest, IL) that has been preset to wait 5 minutes before measurements. Simultaneously, the central BP will be measured in the other upper arm. (WatchBP Office Central; Microlife AG, Widnau, Switzerland). The determination of the right or left upper arm for uAOBP or central BP will be made in a random order by computer generated random codes before the enrollment. | Device | uAOBP & Home BP |
| Home BPAs for the home BP measurements, a validated device (WatchBP Home; Microlife AG, Widnau, Switzerland) will be provided for all subjects allocated to the home BP arm to measure their BP at home. Subjects are requested to take BP in the morning (within 2 hours after awakening) and afternoon before meals for 7 consecutive days before the scheduled clinical visits. BP in the first day of the measurements will be discarded and an average of home BP (all BP reading and BP in the morning and in the afternoon) will be generated and provided for clinicians to guide their treatment. | Device | CBP & Home BP, uAOBP & Home BP |
| CBPFor the uAOBP and CBP, the measurements will be conducted in a quiet room without the presence of clinical personnel. Patients will be seated in a quiet room without talking and taken as an average of 3 measurements with an automated device (HEM-907, Omron Healthcare, Lake Forest, IL) that has been preset to wait 5 minutes before measurements. Simultaneously, the central BP will be measured in the other upper arm. (WatchBP Office Central; Microlife AG, Widnau, Switzerland). The determination of the right or left upper arm for uAOBP or central BP will be made in a random order by computer generated random codes before the enrollment. | Device | CBP & Home BP |
Primary outcome
24 hour mean ambulatory systolic blood pressure
Time frame: 3 months
The change of 24 hour mean ambulatory systolic blood pressure (SBP)
3 secondary outcomes
24 hour mean ambulatory diastolic blood pressure
Time frame: 3 months
left ventricular mass
Time frame: 12 months
SBP and DBP
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Derived from this study: PubMed 31077229Cheng HM, Sung SH, Chen CH, Yu WC, Yang SM, Guo CY, Chuang SY, Chiang CE. Guiding Hypertension Management Using Different Blood Pressure Monitoring Strategies (GYMNs study): comparison of three different blood pressure measurement methods: study protocol for a randomized controlled trial. Trials. 2019 May 10;20(1):265. doi: 10.1186/s13063-019-3366-8.
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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.
Hao-Min Cheng, M.D., Ph.D. principal investigator
Taipei Veterans General Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uAOBP, Home BP and CBP in people with Hypertension, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 12 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 17 Sep 2018. 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 Taiwan. 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?
Contact Hao-Min Cheng, M.D., Ph.D. ((886)-2-28757302 ext. 307, hmcheng@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour mean ambulatory systolic blood pressure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03578848, which also lists 1 linked publication.
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 17 Sep 2018.