ANZCTR - Registration

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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]

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

Permanent pacemakers

Implantable cardioverter defibrillators

Cardiac Resynchronization Therapy

Pulmonary Hypertension

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Cardiovascular

Hypertension

Respiratory

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]

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]

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]

yearly, up to 10 years post enrollment

Secondary outcome [1]

factors associated with development of pulmonary hypertension from historical medical records between 2009 and 2017

Timepoint [1]

yearly, up to 10 years post-enrollment

Secondary outcome [2]

factors associated with the development of right ventricular dysfunction from historical medical records between 2009 and 2017

Timepoint [2]

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?

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)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

None

Address [1]

None

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network Human Research Ethics Committee

Ethics committee address [1]

Port Road
Adelaide SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/06/2020

Approval date [1]

21/07/2020

Ethics approval number [1]

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

Prof Prashanthan Sanders

Address

Royal Adelaide hospital
Port Road
Adelaide, South Australia, 5000

Country

Australia

Phone

+61 8 83139000

Fax

[email protected]

Contact person for public queries

Name

Dian Andina Munawar

Address

Royal Adelaide hospital
Port Road
Adelaide, South Australia, 5000

Country

Australia

Phone

+61 8 8313 9000

Fax

[email protected]

Contact person for scientific queries

Name

Dian Andina Munawar

Address

Royal Adelaide hospital
Port Road
Adelaide, South Australia, 5000

Country

Australia

Phone

+61 8 8313 9000

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8219	Study 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.

Trial Review

Documents added manually

Documents added automatically