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Comparison of Office and Cuffless Ambulatory Blood Pressure-Guided Management in Patients With Hypertension

NCT07770477 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2026-08-18

No results posted yet for this study

Summary

Hypertension is a major risk factor for cardiovascular and cerebrovascular diseases, including stroke and myocardial infarction. Blood pressure (BP) fluctuates throughout the day in response to physical activity, emotional states, and sleep. However, hypertension diagnosis and management are commonly based on BP measurements obtained in the clinic or at home, which may not fully reflect these variations. This can contribute to discrepancies between office and out-of-office BP, including white-coat and masked hypertension.

Ambulatory blood pressure monitoring (ABPM) provides information on BP throughout daily activities and sleep, but conventional cuff-based ABPM may be limited by discomfort, accessibility, and logistical challenges. Recently, cuffless wearable devices have enabled repeated BP monitoring without the use of a conventional inflatable cuff.

The CUFFLESS study is a multicenter, prospective, randomized controlled trial comparing two strategies for the management of hypertension: cuffless ambulatory BP-guided management and conventional office BP-guided management. Participants will be randomly assigned to either management strategy and followed for clinical outcomes. The primary objective is to determine whether hypertension management guided by cuffless ambulatory BP monitoring reduces the occurrence of cardiovascular events compared with management guided by conventional office BP measurements.

Conditions

Interventions

OTHER

Cuffless ambulatory blood pressure-guided management

Participants will undergo 24-hour ambulatory blood pressure monitoring using a cuffless blood pressure monitoring device at least annually. Antihypertensive treatment will be adjusted based on both office and cuffless ambulatory blood pressure measurements, with target systolic blood pressure values of \<140 mmHg for office BP, \<135 mmHg for daytime mean BP, \<120 mmHg for nighttime mean BP, and \<130 mmHg for 24-hour mean BP.

OTHER

Office blood pressure-guided management

Participants will receive conventional hypertension management guided by office blood pressure measurements, with a target office systolic blood pressure of \<140 mmHg.

Sponsors & Collaborators

  • Korean Society of Hypertension

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Hae-Young Lee, MD, PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-24
Primary Completion
2031-12-31
Completion
2036-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07770477 on ClinicalTrials.gov