Cardiovascular Evaluation Before Renal Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University Hospital Muenster.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01064674
First received: February 5, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Coronary Artery Disease
Other: diagnostic procedure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular Diagnostic Before Renal Transplantation: a Prospective Study to Assess Cardiovascular Morbidity Before Renal Transplantation and to Improve Standard Diagnostic Procedures.

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • cardiovascular morbidity [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
before renal transplantation
Patients with CKD IV° to V° who are actually registering for a renal transplantation in our department.
Other: diagnostic procedure
Cardiovascular diagnostic standard procedure before renal transplantation using stress echocardiography and stress myocardial scintigraphy.
Other Name: diagnostic standard procedure

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients with endstage renal disease which are awaiting their ergsitration to our transplantation programm since July 2009 until July 2010.

Criteria

Inclusion Criteria:

  • endstage renal disease
  • preparing for renal transplantation

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064674

Contacts
Contact: Barbara Suwelack, MD 00492518347540 barbara.suwelack@ukmuenster.de
Contact: Viola Malyar, MD 00492518347540 viola.malyar@ukmuenster.de

Locations
Germany
Department of Internal Medicine D, University Hospital Muenster Recruiting
Muenster, Germany, 48149
Contact: Barbara Suwelack, MD    00492518347540    barbara.suwelack@ukmuenster.de   
Contact: Viola Malyar, MD    00492518347540    viola.malyar@ukmuenster.de   
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Barbara Suwelack, MD University Hospital Muenster
Study Chair: Hermann Pavenstädt, MD University Hospital Muenster
Study Chair: Holger Reinecke, MD University Hospital Muenster
Study Chair: Otmar Schober, MD, PhD University Hospital Muenster
  More Information

No publications provided

Responsible Party: PD Dr. med. Barbara Suwelack, Internal Medicine D, University Hospital of Muenster
ClinicalTrials.gov Identifier: NCT01064674     History of Changes
Other Study ID Numbers: KVDiagnostikpratransplantation, HerzundNierenMünster
Study First Received: February 5, 2010
Last Updated: February 5, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
renal transplantation
cardiovascular morbidity
evaluation before renal transplantation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Kidney Diseases
Renal Insufficiency, Chronic
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 21, 2014