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

NCT06394934 | Recruiting

• 1 other identifier: HBPV-ARTMET-2023
• Study Type: observational
• Target: 4,188
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension; Blood Pressure Monitoring, Home; Arteriosclerosis; Metabolic Syndrome X

Keywords

Home Blood Pressure Monitoring; Blood Pressure Variability; Pulse Wave Velocity; Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Association between Home BPV and Additional Arteriosclerosis Indicators

  1 year

• Correlation between Home BPV and Metabolic Indicators

  1 year

Other Outcomes (1)

• Incidence of Major Adverse Cardiovascular Events (MACE)

  3 years

Study Arms (1)

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.

Behavioral: Healthscan App

Interventions

Healthscan App BEHAVIORAL

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.

Home BP Monitoring Cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Korea University Anam Hospital: lead
• Korean Society of Hypertension: collaborator

Study Sites (2)

Korea University Anam Hospital

Seoul, 02841, South Korea

RECRUITING

Korea Univeristy Guro Hospital

Seoul, 08308, South Korea

RECRUITING

Related Publications (7)

• 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.

  PMID: 32203448 BACKGROUND

• 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.

  PMID: 32523429 BACKGROUND

• 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.

  PMID: 22215704 BACKGROUND

• 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.

  PMID: 26630214 BACKGROUND

• 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.

  PMID: 28777132 BACKGROUND

• 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.

  PMID: 35950927 BACKGROUND

• Yu 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.

  PMID: 41209073 DERIVED

MeSH Terms

Conditions

Hypertension; Arteriosclerosis; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hyung Joon Joo, MD PhD

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji Hyeon Baek, BSN

CONTACT

82-2-920-5445; jh2bac@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: May 1, 2024
• Study Start: January 9, 2024
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

KR (2)