Prognostic Value of Central and BracHial Ambulatory Blood Pressure Monitoring in ERSD Patients Treated With HeMOdialysis (C-HEMO)

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

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.

Study Overview

• Status: Unknown
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Other: 48-hour blood pressure ambulatory monitoring

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 Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

• Study Contact: Name: Shikai Yu, MD; Phone Number: +86 18801790211; Email: shikaiyu@yahoo.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Shanghai Tenth People's Hospital, Tongji University School of Medicine
      • Contact: Shikai Yu; Phone Number: +86 18801790211; Email: YuShikai@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with end-stage renal disease treated with hemodialysis.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Publications and helpful links

General Publications

• Ohno Y, Kanno Y, Takenaka T. Central blood pressure and chronic kidney disease. World J Nephrol. 2016 Jan 6;5(1):90-100. doi: 10.5527/wjn.v5.i1.90.
• Karpetas A, Sarafidis PA, Georgianos PI, Protogerou A, Vakianis P, Koutroumpas G, Raptis V, Stamatiadis DN, Syrganis C, Liakopoulos V, Efstratiadis G, Lasaridis AN. Ambulatory recording of wave reflections and arterial stiffness during intra- and interdialytic periods in patients treated with dialysis. Clin J Am Soc Nephrol. 2015 Apr 7;10(4):630-8. doi: 10.2215/CJN.08180814. Epub 2015 Jan 29.
• Sumida K, Molnar MZ, Potukuchi PK, Thomas F, Lu JL, Yamagata K, Kalantar-Zadeh K, Kovesdy CP. Pre-end-stage renal disease visit-to-visit systolic blood pressure variability and post-end-stage renal disease mortality in incident dialysis patients. J Hypertens. 2017 Sep;35(9):1816-1824. doi: 10.1097/HJH.0000000000001376.
• Covic A, Goldsmith DJ, Panaghiu L, Covic M, Sedor J. Analysis of the effect of hemodialysis on peripheral and central arterial pressure waveforms. Kidney Int. 2000 Jun;57(6):2634-43. doi: 10.1046/j.1523-1755.2000.00124.x.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2017
• Primary Completion (Anticipated): October 9, 2019
• Study Completion (Anticipated): October 9, 2020

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 10, 2017

Study Record Updates

• Last Update Posted (Actual): October 30, 2018
• Last Update Submitted That Met QC Criteria: October 28, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: ambulatory blood pressure monitoring; blood pressure variability; central blood pressure
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: C-HEMO001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No