HypertensionNCT06394934
Home Blood Pressure Variability and Its Link to Arteriosclerosis and Metabolic Dysfunction in Hypertensive Patients
An observational study of Hypertension and Blood Pressure Monitoring, Home, run by Korea University Anam Hospital at 2 sites in South Korea.
Trial summary
This observational study investigates the correlation between home blood pressure variability (BPV) and arteriosclerosis, alongside metabolic indicators, in hypertensive patients over a three-year period. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Blood Pressure Monitoring, Home, Arteriosclerosis
- What is being tested?
- Healthscan App
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,188 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 9 Jan 2024to 31 Dec 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult hypertensive patients from various clinical settings, including community clinics and academic hospitals. Participants are broadly recruited to reflect a diverse population regarding age, sex, and severity of hypertension.
Who may be able to join
- Adults aged 19 years or older.
- Diagnosed with hypertension.
- Regular use of antihypertensive medication for at least two years.
- Access to a home blood pressure monitor.
- Comprehensive medical records available for the past year.
Who cannot join
- 1. Participants who are unable to consent or who might not reliably use the home monitoring app.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Korea University Anam Hospital
Seoul, 02841
Hyung Joon Joo, MD, PhD, +8229205445, drjoohj@gmail.com
- Recruiting
Korea Univeristy Guro Hospital
Seoul, 08308
Jah Yeon Choi, MD PhD, kekeruki@korea.ac.kr
About this study
Official title: Impact of Home and Clinical Blood Pressure Variability on Arteriosclerosis and Metabolic Indicators
This observational study investigates the correlation between home blood pressure variability (BPV) and arteriosclerosis, alongside metabolic indicators, in hypertensive patients over a three-year period. The research specifically focuses on the predictive value of home BPV for major adverse cardiovascular events (MACE) including myocardial infarction, stroke, and heart failure hospitalizations. Utilizing a mobile application called Healthscan for daily BP monitoring, the study aims to enhance the understanding of how BPV impacts cardiovascular and metabolic health in a real-world setting.
Read the detailed description
Objective:
This longitudinal, non-randomized study aims to explore the prognostic value of home-measured blood pressure variability (BPV) in predicting arteriosclerosis and metabolic dysfunction in patients with hypertension. By examining the relationship between home BPV and several vascular and metabolic health indicators, this study seeks to validate home BP monitoring as a crucial component of hypertension management.
Study Design:
Participants will be recruited from multiple clinical settings and followed for a three-year period, during which they will use the Healthscan mobile application to record their daily blood pressure readings. The primary outcome measure is the correlation between home BPV and pulse wave velocity, a key marker of arteriosclerosis. Secondary outcomes include other arteriosclerosis indicators such as ankle-brachial index and central systolic blood pressure, as well as metabolic indicators like fasting glucose and lipid profiles.
Methodology:
Approximately 4,188 hypertensive patients over 19 years old, with a history of antihypertensive medication use, will be enrolled. Data collection will be facilitated through the Healthscan app, which participants will use to enter their BP measurements. This data will provide insights into the average blood pressure and variability over specified periods. The study will utilize Pearson or Spearman correlation coefficients to assess the relationships between home BPV and health indicators, with multivariate regression models adjusting for potential confounders.
Ethical Considerations:
The study has been approved by an institutional review board and all participants will provide written informed consent. The study prioritizes data confidentiality and participant privacy, with data being securely stored and managed.
Significance:
By correlating BPV with arteriosclerosis and metabolic parameters, the study could significantly impact clinical practices by reinforcing the role of home BP monitoring in the early detection and management of cardiovascular risks in hypertensive patients. This could potentially lead to more personalized and effective healthcare strategies, ultimately improving patient outcomes in hypertension management.
- Being tested
- Healthscan App
- Keywords
- Home Blood Pressure Monitoring, Blood Pressure Variability, Pulse Wave Velocity, Arteriosclerosis
- Medical subject headings
- Hypertension, Arteriosclerosis, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthscan AppBehavioural
Participants will use the Healthscan mobile application to monitor and record their daily blood pressure at home. The app allows participants to enter their BP measurements, which are then used to calculate blood pressure variability (BPV). The app's use is intended as a non-invasive, practical tool for patient self-management and longitudinal health monitoring in hypertensive individuals.
| Study group | Role | What they receive |
|---|---|---|
| Home BP Monitoring Cohort | Participants in this cohort are hypertensive adults who will use the Healthscan mobile application to monitor and record their blood pressure at home. Receives: Behavioral: Healthscan App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Home Blood Pressure Variability and Pulse Wave Velocity
Measure the strength and nature of the relationship between variability in home-monitored blood pressure and pulse wave velocity, a primary indicator of arteriosclerosis.
Measured: 1 year
Secondary outcomes (2)
Association between Home BPV and Additional Arteriosclerosis Indicators
Assess the correlation of home BPV with other arteriosclerosis indicators including ankle-brachial index, central systolic blood pressure, and second systolic peak blood pressure.
Measured: 1 year
Correlation between Home BPV and Metabolic Indicators
Evaluate the association between home BPV and metabolic health indicators such as fasting glucose levels and lipid profiles (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start9 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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
- 4,188 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Society of Hypertension
- Responsible party
- Principal investigator, Hyung Joon Joo, Korea University Anam Hospital
- Investigators
- Hyung Joon Joo, MD PhD, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394934
- Sponsor's protocol ID
- HBPV-ARTMET-2023
- Status last verified
- Apr 2024
- First submitted
- 21 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: As of now, the decision to share individual participant data (IPD) from this study remains undecided. We recognize the potential value of sharing data to advance scientific knowledge and improve patient care; however, we also prioritize the privacy and confidentiality of our participants. Our final decision will be informed by a comprehensive risk-benefit analysis, ensuring any data-sharing complies with all applicable privacy laws and ethical guidelines. We commit to updating this plan once a conclusive decision has been made, based on these detailed evaluations and consultations.
Publications
Parati G, Torlasco C, Pengo M, Bilo G, Ochoa JE. Blood pressure variability: its relevance for cardiovascular homeostasis and cardiovascular diseases. Hypertens Res. 2020 Jul;43(7):609-620. doi: 10.1038/s41440-020-0421-5. Epub 2020 Mar 13.
PubMed 32203448Rosei EA, Chiarini G, Rizzoni D. How important is blood pressure variability? Eur Heart J Suppl. 2020 Jun;22(Suppl E):E1-E6. doi: 10.1093/eurheartj/suaa061. Epub 2020 Apr 6.
PubMed 32523429Johansson JK, Niiranen TJ, Puukka PJ, Jula AM. Prognostic value of the variability in home-measured blood pressure and heart rate: the Finn-Home Study. Hypertension. 2012 Feb;59(2):212-8. doi: 10.1161/HYPERTENSIONAHA.111.178657. Epub 2012 Jan 3.
PubMed 22215704Juhanoja EP, Niiranen TJ, Johansson JK, Puukka PJ, Jula AM. Agreement between ambulatory, home, and office blood pressure variability. J Hypertens. 2016 Jan;34(1):61-7. doi: 10.1097/HJH.0000000000000772.
PubMed 26630214Ntineri A, Kalogeropoulos PG, Kyriakoulis KG, Aissopou EK, Thomopoulou G, Kollias A, Stergiou GS. Prognostic value of average home blood pressure and variability: 19-year follow-up of the Didima study. J Hypertens. 2018 Jan;36(1):69-76. doi: 10.1097/HJH.0000000000001497.
PubMed 28777132Whelton PK, Carey RM, Mancia G, Kreutz R, Bundy JD, Williams B. Harmonization of the American College of Cardiology/American Heart Association and European Society of Cardiology/European Society of Hypertension Blood Pressure/Hypertension Guidelines: Comparisons, Reflections, and Recommendations. Circulation. 2022 Sep 13;146(11):868-877. doi: 10.1161/CIRCULATIONAHA.121.054602. Epub 2022 Aug 11.
PubMed 35950927Yu HY, Cha JJ, Cho DH, Kim MN, Oh SW, Park JH, Cho KH, Shin SY, Kim EJ, Joo HJ. Impact of home and clinical blood pressure variability on arteriosclerosis and metabolic indicators: a prospective multicenter registry study. Clin Hypertens. 2025 Nov 1;31:e37. doi: 10.5646/ch.2025.31.e37. eCollection 2025.
PubMed 41209073
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Home and Clinical Blood Pressure Variability on Arteriosclerosis and Metabolic Indicators
- ClinicalTrials.gov ID
- NCT06394934
- Acronym / sponsor ID
- HBPV-ARTMET-2023
- Keywords
- Home Blood Pressure Monitoring, Blood Pressure Variability, Pulse Wave Velocity, Arteriosclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,188 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Korean Society of Hypertension
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 May 2024 (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.
This observational study investigates the correlation between home blood pressure variability (BPV) and arteriosclerosis, alongside metabolic indicators, in hypertensive patients over a three-year period. The research specifically focuses on the predictive value of home BPV for major adverse cardiovascular events (MACE) including myocardial infarction, stroke, and heart failure hospitalizations. Utilizing a mobile application called Healthscan for daily BP monitoring, the study aims to enhance the understanding of how BPV impacts cardiovascular and metabolic health in a real-world setting.
Detailed description
Objective:
This longitudinal, non-randomized study aims to explore the prognostic value of home-measured blood pressure variability (BPV) in predicting arteriosclerosis and metabolic dysfunction in patients with hypertension. By examining the relationship between home BPV and several vascular and metabolic health indicators, this study seeks to validate home BP monitoring as a crucial component of hypertension management.
Study Design:
Participants will be recruited from multiple clinical settings and followed for a three-year period, during which they will use the Healthscan mobile application to record their daily blood pressure readings. The primary outcome measure is the correlation between home BPV and pulse wave velocity, a key marker of arteriosclerosis. Secondary outcomes include other arteriosclerosis indicators such as ankle-brachial index and central systolic blood pressure, as well as metabolic indicators like fasting glucose and lipid profiles.
Methodology:
Approximately 4,188 hypertensive patients over 19 years old, with a history of antihypertensive medication use, will be enrolled. Data collection will be facilitated through the Healthscan app, which participants will use to enter their BP measurements. This data will provide insights into the average blood pressure and variability over specified periods. The study will utilize Pearson or Spearman correlation coefficients to assess the relationships between home BPV and health indicators, with multivariate regression models adjusting for potential confounders.
Ethical Considerations:
The study has been approved by an institutional review board and all participants will provide written informed consent. The study prioritizes data confidentiality and participant privacy, with data being securely stored and managed.
Significance:
By correlating BPV with arteriosclerosis and metabolic parameters, the study could significantly impact clinical practices by reinforcing the role of home BP monitoring in the early detection and management of cardiovascular risks in hypertensive patients. This could potentially lead to more personalized and effective healthcare strategies, ultimately improving patient outcomes in hypertension management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home BP Monitoring Cohort | – | Behavioral: Healthscan AppParticipants in this cohort are hypertensive adults who will use the Healthscan mobile application to monitor and record their blood pressure at home. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult hypertensive patients from various clinical settings, including community clinics and academic hospitals. Participants are broadly recruited to reflect a diverse population regarding age, sex, and severity of hypertension.
Key inclusion criteria (5 listed)
- Adults aged 19 years or older.
- Diagnosed with hypertension.
- Regular use of antihypertensive medication for at least two years.
- Access to a home blood pressure monitor.
- Comprehensive medical records available for the past year.
Key exclusion criteria (1 listed)
- 1. Participants who are unable to consent or who might not reliably use the home monitoring app.
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 |
|---|---|---|
| Healthscan AppParticipants will use the Healthscan mobile application to monitor and record their daily blood pressure at home. The app allows participants to enter their BP measurements, which are then used to calculate blood pressure variability (BPV). The app's use is intended as a non-invasive, practical tool for patient self-management and longitudinal health monitoring in hypertensive individuals. | Behavioural | Home BP Monitoring Cohort |
Primary outcome
Correlation between Home Blood Pressure Variability and Pulse Wave Velocity
Time frame: 1 year
Measure the strength and nature of the relationship between variability in home-monitored blood pressure and pulse wave velocity, a primary indicator of arteriosclerosis.
2 secondary outcomes
Association between Home BPV and Additional Arteriosclerosis Indicators
Time frame: 1 year
Correlation between Home BPV and Metabolic Indicators
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Background: PubMed 32203448Parati G, Torlasco C, Pengo M, Bilo G, Ochoa JE. Blood pressure variability: its relevance for cardiovascular homeostasis and cardiovascular diseases. Hypertens Res. 2020 Jul;43(7):609-620. doi: 10.1038/s41440-020-0421-5. Epub 2020 Mar 13.
- Background: PubMed 32523429Rosei EA, Chiarini G, Rizzoni D. How important is blood pressure variability? Eur Heart J Suppl. 2020 Jun;22(Suppl E):E1-E6. doi: 10.1093/eurheartj/suaa061. Epub 2020 Apr 6.
- Background: PubMed 22215704Johansson JK, Niiranen TJ, Puukka PJ, Jula AM. Prognostic value of the variability in home-measured blood pressure and heart rate: the Finn-Home Study. Hypertension. 2012 Feb;59(2):212-8. doi: 10.1161/HYPERTENSIONAHA.111.178657. Epub 2012 Jan 3.
- Background: PubMed 26630214Juhanoja EP, Niiranen TJ, Johansson JK, Puukka PJ, Jula AM. Agreement between ambulatory, home, and office blood pressure variability. J Hypertens. 2016 Jan;34(1):61-7. doi: 10.1097/HJH.0000000000000772.
- Background: PubMed 28777132Ntineri A, Kalogeropoulos PG, Kyriakoulis KG, Aissopou EK, Thomopoulou G, Kollias A, Stergiou GS. Prognostic value of average home blood pressure and variability: 19-year follow-up of the Didima study. J Hypertens. 2018 Jan;36(1):69-76. doi: 10.1097/HJH.0000000000001497.
- Background: PubMed 35950927Whelton PK, Carey RM, Mancia G, Kreutz R, Bundy JD, Williams B. Harmonization of the American College of Cardiology/American Heart Association and European Society of Cardiology/European Society of Hypertension Blood Pressure/Hypertension Guidelines: Comparisons, Reflections, and Recommendations. Circulation. 2022 Sep 13;146(11):868-877. doi: 10.1161/CIRCULATIONAHA.121.054602. Epub 2022 Aug 11.
- Derived from this study: PubMed 41209073Yu HY, Cha JJ, Cho DH, Kim MN, Oh SW, Park JH, Cho KH, Shin SY, Kim EJ, Joo HJ. Impact of home and clinical blood pressure variability on arteriosclerosis and metabolic indicators: a prospective multicenter registry study. Clin Hypertens. 2025 Nov 1;31:e37. doi: 10.5646/ch.2025.31.e37. eCollection 2025.
- Individual participant dataSharing planned: Undecided. As of now, the decision to share individual participant data (IPD) from this study remains undecided. We recognize the potential value of sharing data to advance scientific knowledge and improve patient care; however, we also prioritize the privacy and confidentiality of our participants. Our final decision will be informed by a comprehensive risk-benefit analysis, ensuring any data-sharing complies with all applicable privacy laws and ethical guidelines. We commit to updating this plan once a conclusive decision has been made, based on these detailed evaluations and consultations.
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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.
Hyung Joon Joo, MD PhD principal investigator
Korea University Anam Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Blood Pressure Monitoring, Home, run by Korea University Anam Hospital at 2 sites in South Korea.
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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji Hyeon Baek, BSN (82-2-920-5445, jh2bac@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Home Blood Pressure Variability and Pulse Wave Velocity (time frame: 1 year). 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 NCT06394934, which also lists 7 linked publications.
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 1 May 2024.