Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000878279
Ethics application status
Approved
Date submitted
24/09/2009
Date registered
31/03/2006
Date last updated
9/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Influence of Kidney Graft Function on Beat-to-beat QT Interval Variability
Scientific title
The Influence of Kidney Graft Function on Beat-to-beat QT Interval Variability in Kidney transplant recipients at 1 year post-transplant
Secondary ID [1] 1025 0
CRG030600064
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney graft function at 1 year post-transplant 243741 0
QT interval variability indices 251921 0
Left ventricular mass 251932 0
Sudden cardiac death 297869 0
Condition category
Condition code
Renal and Urogenital 252099 252099 0 0
Kidney disease
Cardiovascular 252100 252100 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study of the beat to beat QT interval variability assessed continuously for 5 minutes in standard 12-lead ECG, single echocardiographic measurement of the left ventricular mass and estimation of renal graft function at 1 year post-transplant
Intervention code [1] 241341 0
Not applicable
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240809 0
QT interval variability indices assessed with electrocardiogram (ECG) in real-time:
- corrected QT interval (QTc),
- QT interval dispersion (QTd),
- standard deviation of normal-to-normal QT interval (SDNN (QT))
- root-mean-square of the successive QT interval difference (rMSSD (QT)),
- QT interval variability index (QTVI).
Timepoint [1] 240809 0
1 year post-transplant
Primary outcome [2] 297561 0
Sudden cardiac death
Timepoint [2] 297561 0
10-year after transplant
Secondary outcome [1] 257479 0
Left ventricular mass and left ventricular mass index, assessed with echocardiogram.
Timepoint [1] 257479 0
1 year post-transplant

Eligibility
Key inclusion criteria
Kidney transplant recipients at 1 year post-transplant.

Stable sinus rhythm with normal atrioventricular conduction on standard electrocardiogram (ECG).

Absence of heart failure symptoms and signs.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients receiving any drugs that are known to influence the QT interval duration.

Clinical, ECG, and echocardiographic evidence of coronary artery disease.

Patients with diabetes mellitus.

Increment of serum creatinine >= 20% at any time during the preceding three months.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2005
Actual
1/06/2005
Date of last participant enrolment
Anticipated
Actual
31/12/2006
Date of last data collection
Anticipated
Actual
31/12/2016
Sample size
Target
70
Accrual to date
Final
68
Recruitment outside Australia
Country [1] 2064 0
Slovenia
State/province [1] 2064 0
Country [2] 2065 0
Slovenia
State/province [2] 2065 0

Funding & Sponsors
Funding source category [1] 243644 0
Hospital
Name [1] 243644 0
University Medical Center Ljubljana
Country [1] 243644 0
Slovenia
Primary sponsor type
Hospital
Name
University Medical Center Ljubljana
Address
Zaloska 7
1000 Ljubljana
Slovenia
Country
Slovenia
Secondary sponsor category [1] 237147 0
University
Name [1] 237147 0
Institute of Physiology, School of Medicine, University of Ljubljana
Address [1] 237147 0
Zaloska 2
1000 Ljubljana
Slovenia
Country [1] 237147 0
Slovenia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243980 0
Ethics committee address [1] 243980 0
Ethics committee country [1] 243980 0
Slovenia
Date submitted for ethics approval [1] 243980 0
Approval date [1] 243980 0
30/05/2005
Ethics approval number [1] 243980 0

Summary
Brief summary
It is hypothesized that renal transplant recipients with renal graft dysfunction are prone to cardiac arrhythmia's and sudden death secondary to changes in cardiac structure and function.
Trial website
Trial related presentations / publications
Arnol M., et al. Left ventricular mass is associated with ventricular repolarization heterogeneity one year after renal transplantation. Am J Transplant 2008; 8: 446-451.
Public notes

Contacts
Principal investigator
Name 30194 0
A/Prof Miha Arnol
Address 30194 0
University Medical Centre Ljubljana
Country 30194 0
Slovenia
Phone 30194 0
+386 1 522 8977
Fax 30194 0
Email 30194 0
miha.arnol@mf.uni-lj.si
Contact person for public queries
Name 13441 0
Miha, Arnol, M.D., Ph.D.
Address 13441 0
Department of Nephrology, Kidney Transplant Center, University Medical Center Ljubljana, Zaloska 7, Ljubljana, 1000, Slovenia
Country 13441 0
Slovenia
Phone 13441 0
+ 386 1 522 3121
Fax 13441 0
Email 13441 0
miha.arnol@mf.uni-lj.si
Contact person for scientific queries
Name 4369 0
Prof, Kandus, Aljosa, M.D., Ph.D.
Address 4369 0
Chief of the Kidney Transplant Center, Department of Nephrology, University Medical Center Ljubljana, Zaloska 7, Ljubljana, 1000, Slovenia
Country 4369 0
Slovenia
Phone 4369 0
+ 386 1 522 3121
Fax 4369 0
Email 4369 0
aljosa.kandus@guest.arnes.si

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.