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Trial registered on ANZCTR


Registration number
ACTRN12620000632998p
Ethics application status
Submitted, not yet approved
Date submitted
6/05/2020
Date registered
29/05/2020
Date last updated
29/05/2020
Date data sharing statement initially provided
29/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Pre- and Post-Operative Blood Pressure Control on the Incidence of Type II Endoleak after Endovascular Aneurysm Repair (BOLD Trial)

Scientific title
The Effect of Targeted Pre- and Post-operative Blood Pressure Control on the Incidence of Type II Endoleak post-Endovascular Aneurysm Repair (EVAR): A Prospective, Randomised, Controlled Trial
Secondary ID [1] 301205 0
NHMRC KP03422

Universal Trial Number (UTN)
U1111-1251-6662
Trial acronym
BOLD (Blood pressure cOntroL for enDoleak)
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Endoleak 317359 0
Hypertension 317360 0
Condition category
Condition code
Surgery 315466 315466 0 0
Surgical techniques
Cardiovascular 315467 315467 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
RCT conducted with two groups, an INTERVENTIONAL group and a CONTROL group. Recruitment to either group is randomized and strictly occurs after the patient has been booked for elective endovascular aneurysm repair (EVAR) for a threshold infrarenal abdominal aortic aneurysm. Both groups will have their co-morbidities and pre-trial medications recorded.
Both groups will be subject to twice-daily blood-pressure monitoring in the community for 3-weeks prior and 6-weeks post-operatively. Participants will be given a standardised and calibrated blood-pressure machine and will be instructed on its use. They will be asked to self-administer the blood-pressure machine and record the results. Results will then be uploaded by the patient onto a secure Google Forms website OR scanned and e-mailed to a secure Project e-mail OR given via phone to the study investigators on a, at a minimum, weekly basis. To corroborate the results, the machines also have 2-month memory which the investigators will interrogate at the end of the study period.

The INTERVENTIONAL group will have weekly appointments, either via Telehealth/phone-call OR in-person (per patient preference) to review their weekly blood-pressure measurements. In this group, the investigators will intend to target a systolic blood-pressure of <120mmHg. At this weekly appointment, if the median blood-pressure is >120mmHg, the investigators are forced to make an adjustment to the current anti-hypertensive regime to intend to meet the systolic target. For safety, we have not clarified a specific anti-hypertensive regime, though will make it clear that the investigators must follow best medical practice. We intend to follow the hierarchical strategy for non-urgent hypertension modification in the independent, non-profit, Queensland-Health endorsed eTG by the Therapeutic Guidelines (TGL) group. Medication decisions will be supervised by a consultant Physician and a senior pharmacist. At this change, the patient's will be given a new prescription for either an increased dose or an additional anti-hypertensive agent. We intend to cover the cost of scripts and ideally, provide access to these prescriptions via the Hospital Pharmacy at the same appointment to ensure adherence. Further, we intend to monitor fidelity to the new regime at these weekly appointments.

The CONTROL group similarly has weekly appointments to ensure BP monitoring is being completed and that the participants are entering the data correctly. In this arm, we will not target to a specific blood-pressure.
Intervention code [1] 317512 0
Treatment: Other
Comparator / control treatment
The CONTROL group will have their blood pressure recorded but not intervened at the same timepoints. This does not include acute management of hypertensive or hypotensive crises.
Control group
Active

Outcomes
Primary outcome [1] 323711 0
Incidence of type II endoleak at 6-weeks, as visualised on CT-angiogram (with Endoleak protocol).
- This would be consistent with surveillance technique for endoleak in current practice.
Timepoint [1] 323711 0
At 6-weeks, post-Endovascular aneurysm repair.
Secondary outcome [1] 382691 0
Sac size (in mm), as visualised on CT-angiogram at 6-weeks.
Timepoint [1] 382691 0
At 6-weeks, post-Endovascular aneurysm repair
Secondary outcome [2] 382692 0
Number/Rate of Aortic Re-Interventions
- This will be assessed through interrogation of the patient's medical charts and re-assessed at the standard 6-week post-operative appointment
Timepoint [2] 382692 0
At 6-weeks, post-Endovascular aneurysm repair
Secondary outcome [3] 382693 0
Number/Rate Aortic Rupture
- This will be assessed through interrogation of the patient's medical charts and re-assessed at the standard 6-week post-operative appointment
Timepoint [3] 382693 0
6-weeks, 6-months, 12-months; from time of Endovascular aneurysm repair

Eligibility
Key inclusion criteria
>50-yers of age
Infrarenal abdominal aortic aneurysm >50mm, including asymptomatic and inflammatory aneurysms; for Endovascular aneurysm repair (EVAR)
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
EVAR for ruptured or symptomatic aneurysms
<50-years of age
Known secondary cause of hypertension that causes concern regarding safety of the protocol; including end-stage renal disease (ESRF), any organ transplant in the 3-months before enrolment
Orthostatic hypotension
o Defined as: one-minute standing SBP <110mmHg at the enrolment appointment
End-stage medical condition with a prognosis <12-months
Recent cardiovascular event (e.g myocardial infarction) and/or recent emergency cardiovascular procedure (incl. percutaneous coronary intervention, CABG)
Current diagnosis of congestive cardiac failure (CCF)
o Defined as; New York Heart Association (NYHA) Class 3-4 symptoms OR echocardiogram-estimate of Left Ventricular Ejection Fraction <30% OR Cardiologist-determined diagnosis of CCF
Arm circumference that prohibits consistent and accurate blood pressure measurement
Participation in another interventional clinical study
Documented cognitive impairment, including a diagnosis of dementia AND/OR active or recent excessive alcohol/substance use <3-months prior to enrolment

Secondary exclusion criteria apply AFTER surgery:
EVAR stent-grafted not used to the manufacturer’s Instructions For Use (IFU)
Ongoing presence of a Type Ia/Ib, III or IV endoleak noted at the time of completion angiography; thereby not excluding treated leaks

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The investigator(s) who evaluate and recruit patients will NOT be aware, at the time of this selection, which group the patient will be allocated too. Randomization will occur AFTER the patient's have been recruited, briefed and have consented to participation in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The data will be analysed according to an intention-to-treat basis. Comparisons between control and intensive groups of the primary outcome of the incidence of type II Endoleaks at 6-weeks will be performed using the Pearson X2 two-sided test. Secondary outcomes will be analysed with Chi-square/Fisher’s exact tests for binary outcomes and t-tests/Mann-Whitney U tests for continuous outcomes. Baseline characteristics between the groups will be compared and all data summarised by means with standard deviations (or medians with interquartile ranges) for continuous variables as appropriate and frequencies with percentages for categorical variables. Statistical significance will be defined as a <0.05 (two-sided).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16616 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 16617 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 30212 0
4029 - Herston
Recruitment postcode(s) [2] 30213 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 305654 0
Hospital
Name [1] 305654 0
Vascular Surgery Department, Royal Brisbane and Women's Hospital
Address [1] 305654 0
Level 3, James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield St, Herston, Queensland 4029
Country [1] 305654 0
Australia
Primary sponsor type
Hospital
Name
Vascular Surgery Department, Royal Brisbane and Women's Hospital
Address
Level 3, James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield St, Herston, Queensland 4029
Country
Australia
Secondary sponsor category [1] 306068 0
None
Name [1] 306068 0
Address [1] 306068 0
Country [1] 306068 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305937 0
RBWH Human Research Ethics Comittee and NMHRC HREA
Ethics committee address [1] 305937 0
Human Research Ethics Office
Lower ground floor, Executive Offices
James Mayne Building
Butterfield Street
HERSTON QLD 4029
Ethics committee country [1] 305937 0
Australia
Date submitted for ethics approval [1] 305937 0
12/05/2020
Approval date [1] 305937 0
Ethics approval number [1] 305937 0
Ethics committee name [2] 306041 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [2] 306041 0
HREC Office,Executive Suites, Lower Ground Floor, Dr James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, Queensland 4029
Ethics committee country [2] 306041 0
Australia
Date submitted for ethics approval [2] 306041 0
12/05/2020
Approval date [2] 306041 0
Ethics approval number [2] 306041 0

Summary
Brief summary
Endovascular aneurysm repair (EVAR) is a widely used surgical technique for the treatment of abdominal aortic aneurysm, an increasingly common pathology. The Achilles heel of EVAR is endoleak, which is the persistence of blood flow into the aneurysm sac following stent deployment. Vascular surgeons are keen for a preventative and non-invasive option to reduce the incidence of type II endoleak, which is the most frequent type and the most common indication for re-intervention after EVAR. Two international studies have suggested that there is a relationship between reduction in peri-operative blood-pressure and the likelihood of developing endoleak.

The BOLD study aims to assess this relationship in a more realistic, achievable and scientifically robust fashion. We will recruit patients who are booked for EVAR electively into two groups, an INTERVENTIONAL group and a CONTROL group. Both groups will self-monitor and record their blood-pressures twice-daily and attend weekly in-person/phone/telehealth appointments. In the former group, we intend to target a systemic blood-pressure of <120mmHg by actively adapting the patient's blood-pressure medications on a weekly basis for the 3-weeks before, and 6-weeks after surgery. We will then compare the outcomes between the groups, with respect to (1) the incidence of type II endoleak at 6-weeks post-operatively, (2) the rate of aortic re-intervention at 6-weeks post-operatively and (3) the rate of aortic rupture at 6-weeks, 6-months and 12-months post-operatively. We hypothesise that the INTERVENTIONAL group will see a significant reduction in these 3 outcomes.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 102134 0
Dr Krishna Pattabathula
Address 102134 0
Vascular Outpatients Department, Level 7, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield St, Herston, Queensland, 4029
Country 102134 0
Australia
Phone 102134 0
+617 3646 7815
Fax 102134 0
+61 7 3646 5220
Email 102134 0
krishna.pattabathula@gmail.com
Contact person for public queries
Name 102135 0
Dr Krishna Pattabathula
Address 102135 0
Vascular Outpatients Department, Level 7, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield St, Herston, Queensland, 4029
Country 102135 0
Australia
Phone 102135 0
+61 3646 7815
Fax 102135 0
+61 7 3646 5220
Email 102135 0
krishna.pattabathula@gmail.com
Contact person for scientific queries
Name 102136 0
Dr Krishna Pattabathula
Address 102136 0
Vascular Outpatients Department, Level 7, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield St, Herston, Queensland, 4029
Country 102136 0
Australia
Phone 102136 0
+61 7 3656 7815
Fax 102136 0
+61 7 3646 5220
Email 102136 0
krishna.pattabathula@gmail.com

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?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 7870 0
Study protocol
Citation [1] 7870 0
Link [1] 7870 0
Email [1] 7870 0
Other [1] 7870 0
Type [2] 8007 0
Informed consent form
Citation [2] 8007 0
Link [2] 8007 0
Email [2] 8007 0
Other [2] 8007 0
Summary results
No Results