Home Blood Pressure Variability and Its Link to Arteriosclerosis and Metabolic Dysfunction in Hypertensive Patients

Hypertension Clinical Trial

Official title:

Impact of Home and Clinical Blood Pressure Variability on Arteriosclerosis and Metabolic Indicators

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06394934
• Other study ID #: HBPV-ARTMET-2023
• Status: Recruiting
• Start date: January 9, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: April 2024
• Source: Korea University Anam Hospital
• Contact: Ji Hyeon Baek, BSN
• Phone: 82-2-920-5445
• Email: jh2bac[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4188
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Adults aged 19 years or older.

2. Diagnosed with hypertension.

3. Regular use of antihypertensive medication for at least two years.

4. Access to a home blood pressure monitor.

5. Comprehensive medical records available for the past year.

Exclusion Criteria:

1. Participants who are unable to consent or who might not reliably use the home monitoring app.

Related Conditions & MeSH terms

• Arteriosclerosis
• Hypertension
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Korea Univeristy Guro Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Anam Hospital	Korean Society of Hypertension

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

Johansson 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. — View Citation

Juhanoja 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. — View Citation

Ntineri 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. — View Citation

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. — View Citation

Rosei 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. — View Citation

Whelton 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	3 years
Primary	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.	1 year
Secondary	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.	1 year
Secondary	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).	1 year