Comparison of Office and Cuffless Ambulatory Blood Pressure-Guided Management in Patients With Hypertension (CUFFLESS)
Comparison of Clinical Outcomes Between Office and Cuffless Ambulatory Blood Pressure-guided Management in Patients With Hypertension
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.
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Ji Young Yoon
- Puhelinnumero: 82-10-2704-4542
- Sähköposti: seecross2846@snu.ac.kr
Tutki yhteystietojen varmuuskopiointi
- Nimi: Seung-Mok Lee, MD
- Puhelinnumero: 82-10-7185-4340
- Sähköposti: mokmom@snu.ac.kr
Opiskelupaikat
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Daegu, Etelä -Korea
- Kyungpook National University Hospital
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Ottaa yhteyttä:
- Jang Hoon Lee, MD, PhD
- Puhelinnumero: 82-53-200-6414
- Sähköposti: ljhmh75@knu.ac.kr
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Seoul, Etelä -Korea
- Korea University Anam Hospital
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Ottaa yhteyttä:
- Hyung Joon Joo, MD, PhD
- Puhelinnumero: 82-2-2286-1214
- Sähköposti: drjoohj@gmail.com
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Seoul, Etelä -Korea
- Korea University Guro Hospital
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Seoul, Etelä -Korea
- Seoul National University Hospital
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Ottaa yhteyttä:
- Hae-Young Lee, MD, PhD
- Puhelinnumero: 82-10-4528-6160
- Sähköposti: hylee612@snu.ac.kr
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Seoul, Etelä -Korea
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Ottaa yhteyttä:
- Woo-Baek Chung, MD, PhD
- Puhelinnumero: 82-2-2258-1134
- Sähköposti: peace816@catholic.ac.kr
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Seoul, Etelä -Korea
- Seoul National University Boramae Medical Center
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Ottaa yhteyttä:
- Hack-Lyoung Kim, MD, PhD
- Puhelinnumero: 82-2-870-3235
- Sähköposti: khl2876@gmail.com
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Seoul, Etelä -Korea
- Kyung Hee University Hospital at Gangdong
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Ottaa yhteyttä:
- Il-Suk Sohn, MD, PhD
- Puhelinnumero: 82-10-8772-4662
- Sähköposti: issohn@khu.ac.kr
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Etelä -Korea
- Seoul National University Bundang Hospital
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Ottaa yhteyttä:
- Kwang-Il Kim, MD, PhD
- Puhelinnumero: 82-31-787-7032
- Sähköposti: kikim907@gmail.com
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Uijeongbu-si, Gyeonggi-do, Etelä -Korea
- The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
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Ottaa yhteyttä:
- Hyo-Suk Ahn, MD, PhD
- Puhelinnumero: 82-10-4223-9201
- Sähköposti: alaco0502@gmail.com
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- 24 hour mean SBP ≥ 130 mmHg by cuffless ambulatory BP monitor
- aged ≥30 and <80 years
- voluntarily decide to participate in this clinical trial and provide written informed consent after being adequately informed.
- willing and able to comply with the requirements of the study protocol
Exclusion Criteria:
- Did not agree with this clinical trial and did not provide informed consent
- Office SBP ≥ 190 mmHg, or diastolic BP (DBP) < 60 mmHg.
- Diagnosed secondary hypertension.
- Hospitalization for stroke, myocardial infarction (MI) or unstable angina within the last 6 months
- Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) within the last 12 months.
- Planned to perform coronary revascularization (PCI or CABG) in the next 12 months.
- History of sustained atrial fibrillation (AF) or ventricular arrhythmias at entry influencing the BP measurement of ring-type cuffless BP monitoring device.
- Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial.
- Underlying heart disease: Hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), rheumatic heart disease or congenital heart disease
- Uncontrolled diabetes mellitus (serum fasting glucose > 200 mg/dL or glycated hemoglobin [HbA1c] >8%).
- Severe liver dysfunction (alanine aminotransferase [ALT] > 3 times the upper limit of normal (ULN) value).
- Severe renal dysfunction (end stage renal disease [ESRD] on dialysis or estimated glomerular filtration rate [eGFR] <30 ml/min/1.73m², or serum creatinine >2.5 mg/dL.
- Malignancy history within 5 years.
- Severe cognitive impairment or mental disorders.
- Participating in other clinical trials other than observation registry
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
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Kokeellinen: Cuffless ambulatory blood pressure-guided management group
Participants assigned to this group will receive hypertension management guided by both office blood pressure and 24-hour ambulatory blood pressure measured using a cuffless BP monitoring device.
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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.
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Active Comparator: Office blood pressure-guided management group
Participants assigned to this group will receive conventional hypertension management guided by office blood pressure measurements.
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Participants will receive conventional hypertension management guided by office blood pressure measurements, with a target office systolic blood pressure of <140 mmHg.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of participants with new cardiovascular events
Aikaikkuna: From randomization until the first occurrence of a primary outcome event or the end of follow-up, up to 5 years
|
New cardiovascular events, defined as a composite of death due to cardiovascular causes, nonfatal stroke, myocardial infarction, acute decompensated heart failure, unstable angina with hospitalization, coronary revascularization, chronic kidney disease, atrial fibrillation and left ventricular hypertrophy.
|
From randomization until the first occurrence of a primary outcome event or the end of follow-up, up to 5 years
|
Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of participants with death due to cardiovascular causes
Aikaikkuna: From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
Occurrence of death due to cardiovascular causes, analyzed as an individual component of the primary composite outcome.
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From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
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Number of participants with nonfatal stroke
Aikaikkuna: From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
Occurrence of nonfatal stroke, analyzed as an individual component of the primary composite outcome.
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From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
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Number of participants with myocardial infarction
Aikaikkuna: From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
Occurrence of myocardial infarction, analyzed as an individual component of the primary composite outcome.
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From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
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Number of participants with coronary revascularization
Aikaikkuna: From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
Occurrence of coronary revascularization, analyzed as an individual component of the primary composite outcome.
|
From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
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Number of participants with acute decompensated heart failure
Aikaikkuna: From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
Occurrence of acute decompensated heart failure, analyzed as an individual component of the primary composite outcome.
|
From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
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Number of participants with unstable angina with hospitalization
Aikaikkuna: From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
Occurrence of unstable angina with hospitalization, analyzed as an individual component of the primary composite outcome.
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From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
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Number of participants with chronic kidney disease
Aikaikkuna: From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
Occurrence of chronic kidney disease, analyzed as an individual component of the primary composite outcome.
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From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
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Number of participants with atrial fibrillation
Aikaikkuna: From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
Occurrence of atrial fibrillation, analyzed as an individual component of the primary composite outcome.
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From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
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Number of participants with left ventricular hypertrophy
Aikaikkuna: From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
Occurrence of left ventricular hypertrophy, analyzed as an individual component of the primary composite outcome.
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From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
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Win ratio for the hierarchical composite outcome
Aikaikkuna: From randomization through the end of follow-up, up to 5 years
|
The hierarchical composite outcome will be analyzed using the win ratio approach, prioritizing events in the following order of clinical importance: (1) death due to cardiovascular causes; (2) nonfatal stroke, myocardial infarction, or acute decompensated heart failure; (3) unstable angina with hospitalization; and (4) coronary revascularization, chronic kidney disease, atrial fibrillation, or left ventricular hypertrophy.
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From randomization through the end of follow-up, up to 5 years
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Muut tulostoimenpiteet
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Long-Term Cardiovascular Outcomes During Extended Follow-up
Aikaikkuna: From randomization through the end of extended follow-up, up to 10 years
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Long-term occurrence of the composite cardiovascular outcome, defined as death due to cardiovascular causes, nonfatal stroke, myocardial infarction, acute decompensated heart failure, unstable angina with hospitalization, coronary revascularization, chronic kidney disease, atrial fibrillation and left ventricular hypertrophy, will be assessed using administrative claims and other available follow-up data.
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From randomization through the end of extended follow-up, up to 10 years
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Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Yhteistyökumppanit
Yhteistyökumppanit
Tutkijat
Tutkijat
- Päätutkija: Hae-Young Lee, MD, PhD, Seoul National University Hospital
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Opiskelun aloitus
Ensisijainen valmistuminen (Arvioitu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- CUFFLESS
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