An observational study in Hypertension, Blood Pressure Monitoring, Home and Arteriosclerosis, sponsored by Korea University Anam Hospital. Recruiting at 2 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by Korea University Anam Hospital · Observational
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 4,188 is above the median of 350 across 1,163 observational studies indexed under Hypertension.
Browse Hypertension studies →Korea University Anam Hospital is the lead sponsor of 112 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in this cohort are hypertensive adults who will use the Healthscan mobile application to monitor and record their blood pressure at home.
Behavioral: Healthscan App
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.
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.
Time frame: 1 year
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.
Time frame: 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).
Time frame: 1 year
Incidence of Major Adverse Cardiovascular Events (MACE)
Monitor and record the incidence of major adverse cardiovascular events including myocardial infarction, stroke, and heart failure hospitalizations among study participants.
Time frame: 3 years
Plan to share: 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.
Started Jan 2024 (actual). Primary completion is estimated for Dec 2024, 11 months after the start.
Of 345 non-industry observational studies under Hypertension, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 111. This study's planned 11 months is below that.
Counting every sponsor, half of 426 studies reached it within 38 months; a quarter within 17 and three quarters within 96.
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