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Prognostic Value of Central and BracHial Ambulatory Blood Pressure Monitoring in ERSD Patients Treated With HeMOdialysis

Prognostic Value of Central and BracHial Ambulatory Blood Pressure Monitoring in ERSD Patients Treated With HeMOdialysis: the C-HEMO Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03306160
Acronym
C-HEMO
Enrollment
900
Registered
2017-10-10
Start date
2017-10-10
Completion date
2020-10-09
Last updated
2018-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

central blood pressure, ambulatory blood pressure monitoring, blood pressure variability

Brief summary

This is a prospective cohort study which aims to explore the significance of brachial and central ambulatory blood pressure monitoring in predicting cardiovascular risk in patients with end stage renal disease who are treated with hemodialysis. Enrolled patients will receive a 48-hour central and brachial ambulatory blood pressure monitoring at its first-time dialysis after enrollment. And their cardiovascular events and deaths at first and third year will be followed-up.

Detailed description

The protocol of this study was approved by the local ethical review board. The including criteria: 1) ESRD treated with hemodialysis for more than 3 months prior to study enrollment; 2) agree to participate the study and sign informed written consent; 3) available for long-term follow-up. The excluding criteria: 1)chronic atrial fibrillation or other cardiac arrhythmia; 2) nonfunctional arteriovenous fistula in the contralateral brachial area of the one used for dialysis; 3) myocardial infarction, angina pectoris and ischemic stroke during the previous month; 4) congestive heart failure class IV based on the New York Heart Association classification; 5) malignancy or any other condition with poor prognosis; 6) antihypertensive treatment during one month prior to enrollment. After enrollment, every patient will receive a question-based interview to obtain medical history and the following examinations and tests: anthropometric parameters measurement including body height, weight; biochemical tests including vein blood and urine. At the first-time dialysis after enrollment, patients will receive 48-hour central and brachial ambulatory blood pressure monitoring using a well validated and commercial device Mobil-O-Graph (IEM, Germany). Brachial blood pressure are measured for each patient before every dialysis for at three month. Then one-year and three-year cardiovascular events and deaths will be followed-up. The primary outcome measures are as follows: deaths and cardiovascular events including nonfatal myocardial infarction, unstable angina, stroke, hospitalization for heart failure, or resuscitated cardiac arrest.

Interventions

OTHER48-hour blood pressure ambulatory monitoring

at first-time dialysis after enrollment, each patient will receive brachial and central blood pressure monitoring for 48 hours using a validate and commercially available device Mobil-O-Graph (IEM, Germany).

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* patients with end-stage renal disease treated with hemodialysis for more than 3 months prior to study enrollment; * agree to participate the study and sign informed written consent; * available for long-term follow-up.

Exclusion criteria

* chronic atrial fibrillation or other cardiac arrhythmia; * nonfunctional arteriovenous fistula in the contralateral brachial area of the one used for dialysis; * myocardial infarction, angina pectoris and ischemic stroke during the previous month; * congestive heart failure class IV based on the New York Heart Association classification; * malignancy or any other condition with poor prognosis; * antihypertensive treatment during 1 month prior to enrollment.

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular events3 yearnonfatal myocardial infarction, unstable angina, stroke, hospitalization for heart failure, or resuscitated cardiac arrest
cardiovascular deaths3 yearcardiovascular deaths
all-cause deaths3 yearall-cause deaths

Countries

China

Contacts

Primary ContactShikai Yu, MD
shikaiyu@yahoo.com+86 18801790211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026