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

• Conditions: End Stage Renal Disease

• Registration Number: NCT03306160
• Lead Sponsor: Shanghai 10th People's Hospital

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.

Study Timeline

• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-10-04
• Study Start: 2017-10-10
• Study First Posted: 2017-10-10
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-28
• Last Update Posted: 2018-10-30
• Primary Completion: 2019-10-09
• Study Completion: 2020-10-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cardiovascular deaths	3 year	cardiovascular deaths
Cardiovascular events	3 year	nonfatal myocardial infarction, unstable angina, stroke, hospitalization for heart failure, or resuscitated cardiac arrest
all-cause deaths	3 year	all-cause deaths

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital, Tongji University School of Medicine; 🇨🇳 Shanghai, Shanghai, China