Clinical trial NCT03306160: Prognostic Value of Central and BracHial Ambulatory Blood Pressure Monitoring in ERSD Patients Treated With HeMOdialysis
Official title: Prognostic Value of Central and BracHial Ambulatory Blood Pressure Monitoring in ERSD Patients Treated With HeMOdialysis: the C-HEMO Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Renal Disease
Keywords: central blood pressure
ambulatory blood pressure monitoring
blood pressure variability
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with end-stage renal disease treated with hemodialysis.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cardiovascular events
timeFrame: 3 year
measure: cardiovascular deaths
timeFrame: 3 year
measure: all-cause deaths
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital, Tongji University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Yawei Xu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.