Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001076268
Ethics application status
Approved
Date submitted
22/06/2018
Date registered
27/06/2018
Date last updated
6/06/2019
Date data sharing statement initially provided
6/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Permanent Pacemaker Response and The Role of Exercise Modality on Maximum Oxygen Consumption During CardioPulmonary Exercise Testing for Heart Transplant Assessment
Scientific title
Permanent Pacemaker Response and The Role of Exercise Modality on Maximum Oxygen Consumption During CardioPulmonary Exercise Testing for Heart Transplant Assessment
Secondary ID [1] 295290 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 308473 0
Condition category
Condition code
Cardiovascular 307450 307450 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trial to be conducted at The Prince Charles Hospital, Brisbane QLD.

This trial will involve patients with established severe heart failure who are already undergoing annual cardiopulmonary exercise testing as part of their functional assessment. These tests are traditionally performed on a stationary bike.

A subset of these patients have permanent pacemakers implanted as part of their heart failure. We hypothesise that these pacemakers do not increment heart rate appropriately when patients are using a stationary bike, therefore giving an inappropriately how maximal anaerobic threshold when assessed with a cardiopulmonary exercise test on a stationary bike.

We aim to recruit 6 patients with heart failure and pacemakers who already undergo a stationary bike cardiopulmonary exercise test and have them undergo a second cardiopulmonary exercise test on a treadmill (intervention group). We will have a second group of 6 patients as a control group - these will be patients with a similar degree of heart failure but who do not have pacemakers.

We hypothesise that pacemaker dependant heart failure patients will have better cardiac function indices when they do cardiopulmonary exercise tests on a treadmill as opposed to a stationary bike.

The principal investigator is Dr Benjamin Gerhardy, a thoracic medicine advanced trainee currently working at The Prince Charles Hospital. Co-investigators including thoracic physicians, a cardiologist and a respiratory scientist.

The tests will be administered/supervised by the principal investigator, with support from a respiratory scientist to ensure appropriate set-up of the equipment and for patient safety.

There will be a time period of no more than 30 days between the initial (stationary bike) cardiopulmonary exercise test and the treadmill cardiopulmonary exercise test, with a minimum time period between the two tests of 7 days.

The protocol will be a fixed incremental protocol, with workload increasing by 16 watts every 2 minutes until exhaustion.

Spirometry on a calibrated spirometer will be performed prior to commencing the cardiopulmonary exercise test.

Throughout the test a variety of parameters will be measured or derived including:
Cardiac: heart rate (and heart rate reserve), blood pressure, cardiac rhythm
Respiratory: respiratory frequency, tidal volume, minute ventilation, ventilatory reserve, peripheral oxygen saturation, oxygen pulse, Ve/VCO2, Ve/VO2
Metabolic: VO2 max, anaerobic threshold, work rate, respiratory exchange ratio
Intervention code [1] 301619 0
Diagnosis / Prognosis
Comparator / control treatment
6 patients with severe heart failure who are undergoing annual cardiopulmonary testing for part of their ongoing cardiopulmonary assessment but who do not have pacemakers present.
Control group
Active

Outcomes
Primary outcome [1] 306421 0
Maximal VO2 obtained (and their difference) between the two testing modalities.
This will be assessed using a Jaeger Vyntus CPX metabolic cart which can measure cardiac and respiratory parameters, and is connected to both the startionary bike and the treadmill..
Timepoint [1] 306421 0
At time of test (one test on stationary bike, one on treadmill).
Secondary outcome [1] 348504 0
Maximum heart rate achieved as per the electrocardiac measuring component of the Jaeger Vyntus CPX metabolic cart.
Timepoint [1] 348504 0
At time of test
Secondary outcome [2] 348505 0
Heart rate response to exercise as per the electrocardiac measuring component of the Jaeger Vyntus CPX metabolic cart
Timepoint [2] 348505 0
during the complete test (dynamic measurement with plot against time at the end)
Secondary outcome [3] 348506 0
Blood pressure response to exercise as measured manually with a sphygmomanometer every 60-90 seconds. This measurement will be taken by the supervising clinician.
Timepoint [3] 348506 0
At baseline (prior to commencement of exercise test) and then every 60-90 seconds during the test, with a measurement at 60-90 seconds post cessation of exercise.
Secondary outcome [4] 348507 0
BORG scores for dyspnoea
Timepoint [4] 348507 0
Prior to commencement of the test, every 2 minutes during the test on a visual analogue scale and immediately upon cessation of the test.
Secondary outcome [5] 348508 0
Maximum workload achieved during test as measured in watts generated through either the treadmill or the stationary bike.
Timepoint [5] 348508 0
At end point (ie immediately prior to cessation) of the test.
Secondary outcome [6] 348509 0
Exercise duration as measured by the Jaeger Vyntus CPX metabolic cart.
Timepoint [6] 348509 0
At time of test
Secondary outcome [7] 348619 0
BORG score for leg fatigue
Timepoint [7] 348619 0
Prior to commencement of test, every two minutes during the test using a visual analogue scale and immediately upon cessation of the test.

Eligibility
Key inclusion criteria
Heart failure diagnosis
Undergoing annual cardiopulmonary exercise testing for the purposes of monitoring cardiac function
Currently under the care of The Prince Charles Hospital Heart Failure service
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent

Standard absolute exclusion criteria for CPET performance including:
- Recent myocardial infarction (7 days)
- Unstable angina
- Uncontrolled arrhythmias
- Syncope
- Active endocarditis
- Acute myocarditis or pericarditis
- Severe aortic stenosis
- Uncontrolled heart failure
- Acute pulmonary embolus or pulmonary infarct
- Thrombosis of the lower extremities
- Suspected dissecting aneurysm
- Uncontrolled asthma
- Pulmonary oedema
- Room air oxygen desaturation < 85%
- Type I hypoxaemic respiratory failure

Exclusion at the preference of the treating cardiologist

Inability to participate in the treadmill CPET due to orthopaedic, biomechanical, neurological or vascular disease, for example hip or knee joint dysfunction limiting their ability to weight bear.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/07/2018
Actual
1/10/2018
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11223 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 23096 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 299883 0
Charities/Societies/Foundations
Name [1] 299883 0
The Prince Charles Hospital Foundation
Country [1] 299883 0
Australia
Primary sponsor type
Individual
Name
Benjamin Gerhardy
Address
C/O Thoracic Medicine Department
The Prince Charles Hospital
627 Rode Road
Chermside Queensland 4032
Country
Australia
Secondary sponsor category [1] 299239 0
None
Name [1] 299239 0
Address [1] 299239 0
Country [1] 299239 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300752 0
Royal Brisbane and Womens Hospital Human Research Ethics Committee [EC00172]
Ethics committee address [1] 300752 0
Human Research Ethics Office
Lower ground floor, Executive Offices
James Mayne Building
Butterfield Street
HERSTON QLD 4029
Ethics committee country [1] 300752 0
Australia
Date submitted for ethics approval [1] 300752 0
14/05/2018
Approval date [1] 300752 0
11/06/2018
Ethics approval number [1] 300752 0
HREC/18/QRBW/247

Summary
Brief summary
This study aims to determine if patients with cardiac failure and pacemakers are being adequately assessed prior to consideration of listing for cardiac transplant. We hypothesise that by using a treadmill instead of a stationary bike as their functional assessment (cardiopulmonary exercise test) we will generate a higher degree of cardiac function and appropriately delay their transplant listing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84698 0
Dr Benjamin Gerhardy
Address 84698 0
C/O Respiratory Department
Mater Hospital, Raymond Terrace
South Brisbane 4101
Country 84698 0
Australia
Phone 84698 0
+61 429 202 373
Fax 84698 0
Email 84698 0
b.gerhardy@hotmail.com
Contact person for public queries
Name 84699 0
Dr Benjamin Gerhardy
Address 84699 0
C/O Respiratory Department
Mater Hospital
Raymond Terrace, Brisbane QLD 4101
Country 84699 0
Australia
Phone 84699 0
+61 429 202 373
Fax 84699 0
Email 84699 0
benjamin.gerhardy@health.qld.gov.au
Contact person for scientific queries
Name 84700 0
Dr Benjamin Gerhardy
Address 84700 0
C/O Thoracic Medicine Department
The Prince Charles Hospital
Rode Rd, Chermside
QLD 4032
Country 84700 0
Australia
Phone 84700 0
+61 429 202 373
Fax 84700 0
Email 84700 0
benjamin.gerhardy@health.qld.gov.au

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?

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.