End Stage Renal DiseaseISARNCT01152892
Risk Stratification in End Stage Renal Disease (ESRD) - ISAR Study
An observational study of End Stage Renal Disease and Chronic Kidney Disease, run by Technical University of Munich at 17 sites in Germany.
Trial summary
The purpose of this study is to evaluate the use of non-invasive markers of the autonomic function and micro- and macrocirculation to predict mortality and cardiovascular end points in end-stage renal disease patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Chronic Kidney Disease, Cardiovascular Event
- How many people
- 500 participants
- Where
- 17 sitesGermany
- Study dates
- Apr 2010to May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with end stage renal disease treated with chronic hemodialysis
Who may be able to join
- Age 18 or older
- End-stage renal disease (ESRD) and receiving maintenance hemodialysis
Who cannot join
- Any clinically significant infection.
- pregnancy
- history of malignant disease with a prognostic life expectancy less than 24 months
- missing of written and informed consent
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Germany17 sites
KFH Dialysis Center
Altötting, Bavaria, 84503
KFH Dialysis Center Dillingen
Dillingen an der Donau, Bavaria, 89407
Praxen Dr. Braun Dingolfing
Dingolfing, Bavaria, 84130
Dialysezentrum München Nord
München, Bavaria, 80807
Dialysezentrum München Solln
München, Bavaria, 81479
KFH Nierenzentrum Giesinger Bahnhof
München, Bavaria, 81539
Department of nephrology, Klinikum rechts der Isar
München, Bavaria, 81675
Nierenzentrum Perlach
München, Bavaria, 81737
Nierenzentrum Bogenhausen
München, Bavaria, 81925
Dialyse im Zentrum
München, 80337
KFH Dialysis Center Elsenheimerstrasse
Munich, Bavaria, 80687
KFH Dialysis Center Munich Schwabing
Munich, Bavaria, 80804
KFH Dialysis Center Munich Harlaching
Munich, Bavaria, 81545
KFH Dialysis Center Neuried
Munich, Bavaria, 82061
KFH Dialysis Center Oberschleißheim
Oberschleißheim, Bavaria, 85764
KFH Dialysis Center Unterhaching
Unterhaching, Bavaria, 82008
KFH Dialysis Center Weißenburg
Weißenburg in Bayern, Bavaria, 80804
About this study
Official title: Risk Stratification in End Stage Renal Disease (ISAR)
The purpose of this study is to evaluate the use of non-invasive markers of the autonomic function and micro- and macrocirculation to predict mortality and cardiovascular end points in end-stage renal disease patients. Furthermore we aim at getting new insight into the insufficiently understood pathophysiology leading to excessively high cardiovascular and non-cardiovascular mortality in dialysis patients.
- Conditions
- End Stage Renal Disease, Chronic Kidney Disease, Cardiovascular Event, Sudden Cardiac Death
- Keywords
- end stage renal disease, chronic kidney disease, cardiovascular event, sudden cardiac death, autonomic function
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Death, Sudden, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality of all causes
24 month follow up
Measured: 24 months
Secondary outcomes (5)
Incidence of cardiovascular events
24 month follow up
Measured: 24 months
Blood pressure drops within a dialysis session
24 month follow up
Measured: 24 months
Incidence of infections requiring antibiotic treatment
24 month follow up
Measured: 24 months
Incidence of shunt thrombosis
24 month follow up
Measured: 24 months
incidence of death and hospitalization due to infection
24 month follow up
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2019 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Else Kröner Fresenius Foundation, AIT Austrian Institute of Technology GmbH, Ludwig-Maximilians - University of Munich, FH Aachen, University of applied sciences
- Responsible party
- Principal investigator, PD Dr. Christoph Schmaderer, Technical University of Munich
- Investigators
- Christoph Schmaderer, M.D., PD, Principal investigator, study chief investigator and head of the nephrological laboratory at the department of nephrology of the Klinikum rechts der Isar of the Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152892
- Sponsor's protocol ID
- ISAR ESRD 01 2010
- Acronym
- ISAR
- Status last verified
- Jan 2016
- First submitted
- 28 Jun 2010
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bauer A, Kantelhardt JW, Barthel P, Schneider R, Makikallio T, Ulm K, Hnatkova K, Schomig A, Huikuri H, Bunde A, Malik M, Schmidt G. Deceleration capacity of heart rate as a predictor of mortality after myocardial infarction: cohort study. Lancet. 2006 May 20;367(9523):1674-81. doi: 10.1016/S0140-6736(06)68735-7.
PubMed 16714188Werfel S, Gunthner R, Hapfelmeier A, Hanssen H, Kotliar K, Heemann U, Schmaderer C. Identification of cardiovascular high-risk groups from dynamic retinal vessel signals using untargeted machine learning. Cardiovasc Res. 2022 Jan 29;118(2):612-621. doi: 10.1093/cvr/cvab040.
PubMed 33576412Gunthner R, Hanssen H, Hauser C, Angermann S, Lorenz G, Kemmner S, Matschkal J, Braunisch MC, Kuechle C, Renders L, Moog P, Wassertheurer S, Baumann M, Hammes HP, Mayer CC, Haller B, Stryeck S, Madl T, Carbajo-Lozoya J, Heemann U, Kotliar K, Schmaderer C. Impaired Retinal Vessel Dilation Predicts Mortality in End-Stage Renal Disease. Circ Res. 2019 Apr 1. doi: 10.1161/CIRCRESAHA.118.314318. Online ahead of print.
PubMed 30929571Hagmair S, Braunisch MC, Bachler M, Schmaderer C, Hasenau AL, Bauer A, Rizas KD, Wassertheurer S, Mayer CC. Implementation and verification of an enhanced algorithm for the automatic computation of RR-interval series derived from 24 h 12-lead ECGs. Physiol Meas. 2017 Jan;38(1):1-14. doi: 10.1088/1361-6579/38/1/1. Epub 2016 Dec 12.
PubMed 27941217Schmaderer C, Tholen S, Hasenau AL, Hauser C, Suttmann Y, Wassertheurer S, Mayer CC, Bauer A, Rizas KD, Kemmner S, Kotliar K, Haller B, Mann J, Renders L, Heemann U, Baumann M. Rationale and study design of the prospective, longitudinal, observational cohort study "rISk strAtification in end-stage renal disease" (ISAR) study. BMC Nephrol. 2016 Oct 26;17(1):161. doi: 10.1186/s12882-016-0374-8.
PubMed 27784272
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification in End Stage Renal Disease (ISAR)
- ClinicalTrials.gov ID
- NCT01152892
- Acronym / sponsor ID
- ISAR / ISAR ESRD 01 2010
- Conditions
- End Stage Renal Disease, Chronic Kidney Disease, Cardiovascular Event, Sudden Cardiac Death
- Keywords
- end stage renal disease, chronic kidney disease, cardiovascular event, sudden cardiac death, autonomic function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Else Kröner Fresenius Foundation, AIT Austrian Institute of Technology GmbH, Ludwig-Maximilians - University of Munich, FH Aachen, University of applied sciences
- Study start
- Apr 2010
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 29 Jun 2010 (estimated)
- 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.
The purpose of this study is to evaluate the use of non-invasive markers of the autonomic function and micro- and macrocirculation to predict mortality and cardiovascular end points in end-stage renal disease patients. Furthermore we aim at getting new insight into the insufficiently understood pathophysiology leading to excessively high cardiovascular and non-cardiovascular mortality in dialysis patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with end stage renal disease treated with chronic hemodialysis
Key inclusion criteria (2 listed)
- Age 18 or older
- End-stage renal disease (ESRD) and receiving maintenance hemodialysis
Key exclusion criteria (4 listed)
- Any clinically significant infection.
- pregnancy
- history of malignant disease with a prognostic life expectancy less than 24 months
- missing of written and informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality of all causes
Time frame: 24 months
24 month follow up
5 secondary outcomes
Incidence of cardiovascular events
Time frame: 24 months
Blood pressure drops within a dialysis session
Time frame: 24 months
Incidence of infections requiring antibiotic treatment
Time frame: 24 months
Incidence of shunt thrombosis
Time frame: 24 months
incidence of death and hospitalization due to infection
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
- Background: PubMed 16714188Bauer A, Kantelhardt JW, Barthel P, Schneider R, Makikallio T, Ulm K, Hnatkova K, Schomig A, Huikuri H, Bunde A, Malik M, Schmidt G. Deceleration capacity of heart rate as a predictor of mortality after myocardial infarction: cohort study. Lancet. 2006 May 20;367(9523):1674-81. doi: 10.1016/S0140-6736(06)68735-7.
- Derived from this study: PubMed 33576412Werfel S, Gunthner R, Hapfelmeier A, Hanssen H, Kotliar K, Heemann U, Schmaderer C. Identification of cardiovascular high-risk groups from dynamic retinal vessel signals using untargeted machine learning. Cardiovasc Res. 2022 Jan 29;118(2):612-621. doi: 10.1093/cvr/cvab040.
- Derived from this study: PubMed 30929571Gunthner R, Hanssen H, Hauser C, Angermann S, Lorenz G, Kemmner S, Matschkal J, Braunisch MC, Kuechle C, Renders L, Moog P, Wassertheurer S, Baumann M, Hammes HP, Mayer CC, Haller B, Stryeck S, Madl T, Carbajo-Lozoya J, Heemann U, Kotliar K, Schmaderer C. Impaired Retinal Vessel Dilation Predicts Mortality in End-Stage Renal Disease. Circ Res. 2019 Apr 1. doi: 10.1161/CIRCRESAHA.118.314318. Online ahead of print.
- Derived from this study: PubMed 27941217Hagmair S, Braunisch MC, Bachler M, Schmaderer C, Hasenau AL, Bauer A, Rizas KD, Wassertheurer S, Mayer CC. Implementation and verification of an enhanced algorithm for the automatic computation of RR-interval series derived from 24 h 12-lead ECGs. Physiol Meas. 2017 Jan;38(1):1-14. doi: 10.1088/1361-6579/38/1/1. Epub 2016 Dec 12.
- Derived from this study: PubMed 27784272Schmaderer C, Tholen S, Hasenau AL, Hauser C, Suttmann Y, Wassertheurer S, Mayer CC, Bauer A, Rizas KD, Kemmner S, Kotliar K, Haller B, Mann J, Renders L, Heemann U, Baumann M. Rationale and study design of the prospective, longitudinal, observational cohort study "rISk strAtification in end-stage renal disease" (ISAR) study. BMC Nephrol. 2016 Oct 26;17(1):161. doi: 10.1186/s12882-016-0374-8.
Related trials for End Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
Christoph Schmaderer, M.D., PD principal investigator
study chief investigator and head of the nephrological laboratory at the department of nephrology of the Klinikum rechts der Isar of the Technical University of Munich
17 sites 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 and Chronic Kidney Disease, run by Technical University of Munich at 17 sites in Germany.
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 2 inclusion and 4 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 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality of all causes (time frame: 24 months). 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 NCT01152892, which also lists 5 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 26 Jan 2016.