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

NCT03306160 | Unknown

• 1 other identifier: C-HEMO001
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

central blood pressure; ambulatory blood pressure monitoring; blood pressure variability

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

48-hour blood pressure ambulatory monitoring OTHER

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with end-stage renal disease treated with hemodialysis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 28399042 BACKGROUND

• 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.

  PMID: 25635033 BACKGROUND

• 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.

  PMID: 10844634 BACKGROUND

• 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.

  PMID: 26788468 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yawei Xu, MD, PhD

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shikai Yu, MD

CONTACT

+86 18801790211; shikaiyu@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The chief director of department of cardiology

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 10, 2017
• Study Start: October 10, 2017
• Primary Completion: October 9, 2019
• Study Completion: October 9, 2020
• Last Updated: October 30, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)