Chronic Kidney DiseaseNCT01064674
Cardiovascular Evaluation Before Renal Transplantation
An observational study of Chronic Kidney Disease and Coronary Artery Disease, run by University Hospital Muenster at 1 site in Germany.
Trial summary
Due to rising importance of cardiovascular disease before and after renal transplantation we have changed our standard diagnostic procedure and perform stress echocardiography and myocardial scintigraphy. We would like to monitor these results and the outcome of our patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Coronary Artery Disease
- What is being tested?
- diagnostic procedure
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to Sep 2010
- 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: All patients with endstage renal disease which are awaiting their ergsitration to our transplantation programm since July 2009 until July 2010.
Who may be able to join
- endstage renal disease
- preparing for renal transplantation
Who cannot join
- children (< 18 years)
- women who are pregnant or nursing
- patients who are also awaiting heart transplantation or have already a heart transplant
- severe mental illness
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Internal Medicine D, University Hospital Muenster
Münster, 48149
Barbara Suwelack, MD, 00492518347540, barbara.suwelack@ukmuenster.de
Viola Malyar, MD, 00492518347540, viola.malyar@ukmuenster.de
About this study
Official title: Cardiovascular Diagnostic Before Renal Transplantation: a Prospective Study to Assess Cardiovascular Morbidity Before Renal Transplantation and to Improve Standard Diagnostic Procedures.
Due to rising importance of cardiovascular disease before and after renal transplantation we have changed our standard diagnostic procedure and perform stress echocardiography and myocardial scintigraphy. We would like to monitor these results and the outcome of our patients.
Read the detailed description
Chronic kidney disease is a well-known risk factor for cardiovascular disease. Patients waiting for a renal transplantation usually undergo an extensive diagnostic procedure to avoid complications after transplantation such as neoplasia or inflammation. In the past years, cardiovascular complications before and after renal transplantation have gained more attention. We therefore have changed our standard diagnostic procedure before renal transplantation and perform stress echocardiography and myocardial scintigraphy. Thus we would like to evaluate our new standard diagnostic procedure and observe the results of these diagnostic procedures as well as their impact on clinical outcome.
- Conditions
- Chronic Kidney Disease, Coronary Artery Disease
- Being tested
- diagnostic procedure
- Keywords
- renal transplantation, cardiovascular morbidity, evaluation before renal transplantation
- Medical subject headings
- Renal Insufficiency, Chronic, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic procedureOther
Also called diagnostic standard procedure
Cardiovascular diagnostic standard procedure before renal transplantation using stress echocardiography and stress myocardial scintigraphy.
| Study group | Role | What they receive |
|---|---|---|
| before renal transplantation | Patients with CKD IV° to V° who are actually registering for a renal transplantation in our department. Receives: Other: diagnostic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular morbidity
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionJun 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Barbara Suwelack, MD, Principal investigator, University Hospital MuensterHermann Pavenstädt, MD, Study chair, University Hospital MuensterHolger Reinecke, MD, Study chair, University Hospital MuensterOtmar Schober, MD, PhD, Study chair, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064674
- Sponsor's protocol ID
- KVDiagnostikpratransplantation
- Other IDs
- HerzundNierenMünster
- Status last verified
- Jan 2010
- First submitted
- 5 Feb 2010
- Last updated
- 8 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Diagnostic Before Renal Transplantation: a Prospective Study to Assess Cardiovascular Morbidity Before Renal Transplantation and to Improve Standard Diagnostic Procedures.
- ClinicalTrials.gov ID
- NCT01064674
- Acronym / sponsor ID
- KVDiagnostikpratransplantation
- Conditions
- Chronic Kidney Disease, Coronary Artery Disease
- Keywords
- renal transplantation, cardiovascular morbidity, evaluation before renal transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 8 Feb 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.
Due to rising importance of cardiovascular disease before and after renal transplantation we have changed our standard diagnostic procedure and perform stress echocardiography and myocardial scintigraphy. We would like to monitor these results and the outcome of our patients.
Detailed description
Chronic kidney disease is a well-known risk factor for cardiovascular disease. Patients waiting for a renal transplantation usually undergo an extensive diagnostic procedure to avoid complications after transplantation such as neoplasia or inflammation. In the past years, cardiovascular complications before and after renal transplantation have gained more attention. We therefore have changed our standard diagnostic procedure before renal transplantation and perform stress echocardiography and myocardial scintigraphy. Thus we would like to evaluate our new standard diagnostic procedure and observe the results of these diagnostic procedures as well as their impact on clinical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| before renal transplantation | – | Other: diagnostic procedurePatients with CKD IV° to V° who are actually registering for a renal transplantation in our department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with endstage renal disease which are awaiting their ergsitration to our transplantation programm since July 2009 until July 2010.
Key inclusion criteria (2 listed)
- endstage renal disease
- preparing for renal transplantation
Key exclusion criteria (4 listed)
- children (< 18 years)
- women who are pregnant or nursing
- patients who are also awaiting heart transplantation or have already a heart transplant
- severe mental illness
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 |
|---|---|---|
| diagnostic procedureAlso: diagnostic standard procedureCardiovascular diagnostic standard procedure before renal transplantation using stress echocardiography and stress myocardial scintigraphy. | Other | before renal transplantation |
Primary outcome
cardiovascular morbidity
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2010.
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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.
Barbara Suwelack, MD principal investigator
University Hospital Muenster
Hermann Pavenstädt, MD study chair
University Hospital Muenster
Holger Reinecke, MD study chair
University Hospital Muenster
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 Chronic Kidney Disease and Coronary Artery Disease, run by University Hospital Muenster at 1 site 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 8 Feb 2010. 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 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?
Contact Barbara Suwelack, MD (00492518347540, barbara.suwelack@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular morbidity (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2010.