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Trial registered on ANZCTR


Registration number
ACTRN12620000999932
Ethics application status
Approved
Date submitted
12/06/2020
Date registered
6/10/2020
Date last updated
6/10/2020
Date data sharing statement initially provided
6/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Transvenous Cardiac Implantable Devices and Pulmonary Hypertension: An Echocardiographic Evaluation in a Cohort Study
Scientific title
Transvenous Cardiac Implantable Devices and Pulmonary Hypertension: An Echocardiographic Evaluation in a Cohort Study
Secondary ID [1] 301488 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with cardiac implantable electronic devices 317815 0
Permanent pacemakers 318096 0
Implantable cardioverter defibrillators 318097 0
Cardiac Resynchronization Therapy 318098 0
Pulmonary Hypertension 318118 0
Condition category
Condition code
Cardiovascular 315874 315874 0 0
Other cardiovascular diseases
Cardiovascular 316141 316141 0 0
Hypertension
Respiratory 316142 316142 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants who have previously had a transvenous cardiac device implanted between 2009 to 2017 will be followed up with an annual echocardiogram up to 10 years post-cardiac device implantation, to investigate pulmonary artery pressure.
Intervention code [1] 317811 0
Early Detection / Screening
Comparator / control treatment
an age-matched group of patients without CIED undergoing echocardiogram between 2009 to 2017 will be established to serve as controls.
Control group
Active

Outcomes
Primary outcome [1] 324105 0
the proportion of patients with pulmonary hypotension will be determined using echocardiogram data from each participant collected from historical electronic medical records between 2009 and 2017
Timepoint [1] 324105 0
yearly, up to 10 years post enrollment
Secondary outcome [1] 383772 0
factors associated with development of pulmonary hypertension from historical medical records between 2009 and 2017
Timepoint [1] 383772 0
yearly, up to 10 years post-enrollment
Secondary outcome [2] 384960 0
factors associated with the development of right ventricular dysfunction from historical medical records between 2009 and 2017
Timepoint [2] 384960 0
yearly, up to 10 years post-enrollment

Eligibility
Key inclusion criteria
1. All patients who underwent CIED implantation between 2009 and 2017 will be reviewed for inclusion
2. The eligible participants will only be identified from a single centre (Centre for Heart Rhythm Hospital/Royal Adelaide Hospital)
3. The control participants are the age-matched patients who have not had a CIED implanted but who have had an annual echocardiogram follow-up
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- patients without any follow-up of at least two echocardiograms (first within 6 months and the second greater than 1 year following implant)

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
List of participants will be taken from the list of patients who underwent CIED implants from 2007 to 2017.
Normally distributed continuous data will be expressed as mean ± standard deviation and tested with unpaired t-tests between groups. Skewed distributions will be expressed as median and inter-quartile and means tested using Mann-Whitney U. All significant covariates in the univariate analysis were included in the imputation model to improve the accuracy of generating replacements for missing values. A Cox proportional-hazards analysis was performed to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) Multivariable models additionally adjusted for age and gender. Variables in the multivariable models represent the most common confounding or mediating factors of the association between CIED and high likelihood of PH. Survival curves with 95% CIs and corresponding number at risk tables are presented. A p value < 0.005 was considered to be statistically significant.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
21/07/2020
Date of last participant enrolment
Anticipated
Actual
21/07/2020
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
1100
Accrual to date
Final
1572
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 16897 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 30548 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 305946 0
Self funded/Unfunded
Name [1] 305946 0
None
Country [1] 305946 0
Primary sponsor type
University
Name
Centre for Heart Rhythm Disorders, University of Adelaide
Address
62 Beulah Road, Norwood,
South Australia 5067
Country
Australia
Secondary sponsor category [1] 306401 0
None
Name [1] 306401 0
None
Address [1] 306401 0
None
Country [1] 306401 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306189 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 306189 0
Port Road
Adelaide SA 5000
Ethics committee country [1] 306189 0
Australia
Date submitted for ethics approval [1] 306189 0
26/06/2020
Approval date [1] 306189 0
21/07/2020
Ethics approval number [1] 306189 0

Summary
Brief summary
Previous case studies have shown that intracardiac lead thrombus can cause pulmonary embolism (PE). However, the incidence of new or worsening pulmonary hypertension after cardiovascular implantable electronic devices (CIED) lead placement has not been well investigated. Pulmonary hypertension after CIED implantation will subsequently result in right heart failure and increase morbidity and mortality. This study is aimed to:
I. Determine the incidence and factors associated with development of pulmonary hypertension and right ventricular dysfunction in patients with CIEDs.
II. Determine the role of anticoagulation in the prevention of pulmonary hypertension in patients with CIEDs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68950 0
Prof Prashanthan Sanders
Address 68950 0
Royal Adelaide hospital
Port Road
Adelaide, South Australia, 5000
Country 68950 0
Australia
Phone 68950 0
+61 8 83139000
Fax 68950 0
Email 68950 0
[email protected]
Contact person for public queries
Name 68951 0
Dian Andina Munawar
Address 68951 0
Royal Adelaide hospital
Port Road
Adelaide, South Australia, 5000
Country 68951 0
Australia
Phone 68951 0
+61 8 8313 9000
Fax 68951 0
Email 68951 0
[email protected]
Contact person for scientific queries
Name 68952 0
Dian Andina Munawar
Address 68952 0
Royal Adelaide hospital
Port Road
Adelaide, South Australia, 5000
Country 68952 0
Australia
Phone 68952 0
+61 8 8313 9000
Fax 68952 0
Email 68952 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8219Study protocol    371473-(Uploaded-25-07-2020-05-15-14)-Study-related document.pdf



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.