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:

MedlinePlus related topics: Chronic Kidney Disease Coronary Artery Disease Kidney Transplantation

U.S. FDA Resources

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

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
Kidney Failure, Chronic
Heart Diseases

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 16, 2013

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