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

End Stage Renal Disease Clinical Trial

— C-HEMO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03306160
• Other study ID #: C-HEMO001
• Status: Recruiting
• Start date: October 10, 2017
• Est. completion date: October 9, 2020

Study information

• Verified date: October 2018
• Source: Shanghai 10th People's Hospital
• Contact: Shikai Yu, MD
• Phone: +86 18801790211
• Email: shikaiyu[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: October 9, 2020
• Est. primary completion date: October 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• 48-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).

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital, Tongji University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular events	nonfatal myocardial infarction, unstable angina, stroke, hospitalization for heart failure, or resuscitated cardiac arrest	3 year
Primary	cardiovascular deaths	cardiovascular deaths	3 year
Primary	all-cause deaths	all-cause deaths	3 year