End Stage Renal DiseaseC-HEMONCT03306160
Prognostic Value of Central and BracHial Ambulatory Blood Pressure Monitoring in ERSD Patients Treated With HeMOdialysis
An observational study of End Stage Renal Disease, run by Shanghai 10th People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- 48-hour blood pressure ambulatory monitoring
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2017to 9 Oct 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with end-stage renal disease treated with hemodialysis.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200072
Shikai Yu, +86 18801790211, YuShikai@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- End Stage Renal Disease
- Being tested
- 48-hour blood pressure ambulatory monitoring
- Keywords
- central blood pressure, ambulatory blood pressure monitoring, blood pressure variability
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
48-hour blood pressure ambulatory monitoringOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular events
nonfatal myocardial infarction, unstable angina, stroke, hospitalization for heart failure, or resuscitated cardiac arrest
Measured: 3 year
cardiovascular deaths
cardiovascular deaths
Measured: 3 year
all-cause deaths
all-cause deaths
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start10 Oct 2017
- Primary completion9 Oct 2019 (estimated)
- Study completion9 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yawei Xu, MD, PhD, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306160
- Sponsor's protocol ID
- C-HEMO001
- Acronym
- C-HEMO
- Status last verified
- Oct 2018
- First submitted
- 28 Sep 2017
- Last updated
- 30 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28399042Karpetas 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.
PubMed 25635033Covic 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.
PubMed 10844634Ohno 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.
PubMed 26788468
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Central and BracHial Ambulatory Blood Pressure Monitoring in ERSD Patients Treated With HeMOdialysis: the C-HEMO Study
- ClinicalTrials.gov ID
- NCT03306160
- Acronym / sponsor ID
- C-HEMO / C-HEMO001
- Conditions
- End Stage Renal Disease
- Keywords
- central blood pressure, ambulatory blood pressure monitoring, blood pressure variability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 9 Oct 2019 (estimated)
- Study completion
- 9 Oct 2020 (estimated)
- First posted
- 10 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with end-stage renal disease treated with hemodialysis.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 48-hour blood pressure ambulatory monitoringat 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). | Other | – |
Primary outcome
Cardiovascular events
Time frame: 3 year
nonfatal myocardial infarction, unstable angina, stroke, hospitalization for heart failure, or resuscitated cardiac arrest
cardiovascular deaths
Time frame: 3 year
cardiovascular deaths
all-cause deaths
Time frame: 3 year
all-cause deaths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Background: PubMed 28399042Sumida 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.
- Background: PubMed 25635033Karpetas 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.
- Background: PubMed 10844634Covic 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.
- Background: PubMed 26788468Ohno 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yawei Xu, MD, PhD principal investigator
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shikai Yu, MD (+86 18801790211, shikaiyu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular events (time frame: 3 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03306160, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.