Guiding Hypertension Management Using Different Blood Pressure Monitoring Strategies

NCT03578848 | Unknown DMC

• 1 other identifier: 2018-05-009A
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypertension

Keywords

blood pressure monitoring; sphygmomanometer

Outcome Measures

Primary Outcomes (1)

• 24 hour mean ambulatory systolic blood pressure

  The change of 24 hour mean ambulatory systolic blood pressure (SBP)

  3 months

Secondary Outcomes (3)

• 24 hour mean ambulatory diastolic blood pressure

  3 months

• left ventricular mass

  12 months

• SBP and DBP

  12 months

Study Arms (2)

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.

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.

Device: Home BP; Device: CBP

Interventions

uAOBP DEVICE

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.

uAOBP & Home BP

Home BP DEVICE

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.

CBP & Home BP; uAOBP & Home BP

CBP DEVICE

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.

CBP & Home BP

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 111, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 31077229 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hao-Min Cheng, M.D., Ph.D.

  Taipei Veterans General Hospital, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao-Min Cheng, M.D., Ph.D.

CONTACT

(886)-2-28757302; hmcheng@vghtpe.gov.tw

Shu-Mei Yang, Ph.D

CONTACT

(886)-2-55681049; stellarsirius@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Each patient will be randomly assigned, using a standard computer protocol at the General Clinical Research Center, Taipei Veterans General Hospital, Taipei, Taiwan, to intervention in a 1:1:1 ratio to home BP, uAOBP, or central BP using sealed opaque envelopes (sequentially numbered). The study coordinator will oversee the enrollment and intervention assignment and keep allocation concealment. The caring physicians will remain blinded to the allocation by providing them with the measured BP values through a standardized report form without the knowledge of the used BP monitoring devices.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 6, 2018
• Study Start: June 6, 2018
• Primary Completion: June 1, 2019
• Study Completion: March 1, 2020
• Last Updated: September 17, 2018

Record last verified: 2018-09

Locations

TW (1)