Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394934
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-21
Brief Title:
Home Blood Pressure Variability and Its Link to Arteriosclerosis and Metabolic Dysfunction in Hypertensive Patients
Sponsor:
Korea University Anam Hospital
Organization:
Korea University Anam Hospital
Study Overview
Official Title:
Impact of Home and Clinical Blood Pressure Variability on Arteriosclerosis and Metabolic Indicators
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 4188 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
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 4188 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None