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Trial registered on ANZCTR


Registration number
ACTRN12616001225404
Ethics application status
Approved
Date submitted
29/08/2016
Date registered
5/09/2016
Date last updated
13/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A validation study to investigate the role of Central Hypertension in Atrial Fibrillation Outcome
Scientific title
A prospective validation study to Investigate the role of Multi-modality central PULSE wave evaluation and its impact on atrial fibrillation (AF) outcome. (IMPULSE AF)- Validation Study
Secondary ID [1] 290037 0
Nil
Universal Trial Number (UTN)
U1111-1186-9931
Trial acronym
IMPULSE AF-Validation Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 300083 0
Hypertension 300084 0
Condition category
Condition code
Cardiovascular 299969 299969 0 0
Other cardiovascular diseases
Cardiovascular 299970 299970 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
9
Target follow-up type
Months
Description of intervention(s) / exposure
IMPULSE AF is a pilot study to validate our non-invasive central pressure assessment against invasive aortic pressure.
Central Hypertension will be validated in AF by comparing invasive assessment during AF ablation with non-invasive appraisal of central pressure indices during AF ablation.
Invasive central BP waveform will be recorded for 5-10 mins with pig tail catheter in aorta at the time of into-atrial septal puncture.
Non-invasive assessment of central pressure wave morphology and pulse wave velocity (PWV) appraisal between descending and abdominal aorta by echocardiography and carotid
femoral PWV by Sphygmocor (cuff based device over the thigh) will be done at the same time.
Invasive BP monitoring will be performed by anaesthetics as usual in AF after that.
The validation of the non-invasive assessment of central pressure indices (morphology and PWV) will be performed in AF and sinus rhythm during AF ablation.
In the next step, We will take this opportunity to look at the earliest change in central pressure wave form with reversion in sinus rhythm.
Intervention code [1] 295762 0
Early Detection / Screening
Comparator / control treatment
Non-invasively CMR, echo and Sphygmocor are validated means of looking at central pressure wave in sinus rhythm but not in AF.
In the validation step we will like to validate the non-invasive method by comparing it with invasive assessment in AF.
In next step the validated non-invasive method or methods will be employed to look into central pressure wave change with change in rhythm from sinus to AF or vice versa.
Control group
Active

Outcomes
Primary outcome [1] 299453 0
Validation of non-invasive central pressure indices appraisal method in AF by comparing it with invasive assessment during AF ablation.
Invasive assessment will be performed by the pig tail catheter placed in the aorta at the time of intra-atrial septal puncture.
Non invasive assessment will be done by echocardiography and cuff based device (Sphygmocor) applied at thigh. Central Pressure wave morphology and velocity will be computed by these techniques.
Timepoint [1] 299453 0
At the time of ablation
Primary outcome [2] 299454 0
To record and review earliest marker of change in central pressure wave morphology or velocity with change in rhythm i.e; AF or sinus rhythm. During AF ablation the transformation in central pressure with change in rhythm will be studied with invasive (via pig tail) and non-invasive methods (echo, Sphygmocor).
In the validation phase we are not planning to follow up our patients for the study purpose. during follow up appointments.
Timepoint [2] 299454 0
For validation study, we are only collecting data at the time of validation and 4-6 weeks post ablation re CMR study. Further follow ups will be organised as a protocol for our next study.
Secondary outcome [1] 327206 0
Validation of invasive central pressure recorded during AF ablation with non-invasive central pressure assessment by echocardiography and Sphygmocor device during sinus rhythm
Timepoint [1] 327206 0
At the time of ablation

Eligibility
Key inclusion criteria
Patients undergoing AF ablation for symptomatic PAF
Age range 18-80 yrs
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients contraindicated for exercise testing according to American Heart
Association (AHA) guidelines.
2. Acute decompensated heart failure
3. Unstable angina or recent MI (less than 4 weeks)
4. Hemodynamic instability
5. Connective tissue disorders involving aortic root.
6. Moderate to severe aortic valve insufficiency
7. Advanced valvular heart disease
8. Constrictive or restrictive cardiomyopathy
9. Pregnancy

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample Size Calculation:
ARTERY society guidelines recommend enrolment of 30 patients in validation study. For our pilot study we will recruit 30 patients to allow normal distribution of data as well as addressing the Std. deviation of Sphygmocor device (0.5m/s). A sample size of 30 will give us a beat of 0.8 to correlate invasive and non-invasive evaluation of central pressure with alpha of 0.05.
Statistical Analysis:
Continuous variables will be reported as mean with standard deviation (SD). Results will be expressed as mean +/- SEM with p value of <0.05 considered statistically significant. Intra-class correlation analysis, Student’s t-test and Bland– Altman plots will be used to assess the agreement between the invasive and non-invasive central pressure measurements. Pearson’s method will be used for correlation analysis for the differences between the mean values of the non-invasive and invasive measurements.
Other ad hoc summary or analysis may be performed as necessary.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/09/2016
Actual
20/09/2016
Date of last participant enrolment
Anticipated
31/12/2017
Actual
30/01/2018
Date of last data collection
Anticipated
28/02/2018
Actual
31/03/2018
Sample size
Target
30
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 6553 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 11641 0
Ashford Community Hospital - Ashford
Recruitment postcode(s) [1] 14151 0
5000 - Adelaide
Recruitment postcode(s) [2] 23688 0
5035 - Ashford

Funding & Sponsors
Funding source category [1] 294406 0
Hospital
Name [1] 294406 0
Royal Adelaide Hospital
Country [1] 294406 0
Australia
Primary sponsor type
Hospital
Name
CHRD, Royal Adelaide Hospital,
Address
Centre of Heart Rhythm Disorders (CHRD), Level 5 Royal Adelaide Hospital, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 293254 0
None
Name [1] 293254 0
Address [1] 293254 0
Country [1] 293254 0
Other collaborator category [1] 279183 0
Individual
Name [1] 279183 0
Professor Prash Sanders
Address [1] 279183 0
CVC, 62 Beulah Road Norwood, Adelaide SA 5067
Country [1] 279183 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295826 0
CALHN Human Research Ethics Committee
Ethics committee address [1] 295826 0
CALHN HUMAN RESEARCH ETHICS
Royal Adelaide Hospital Level 4 Women’s Health Centre
North Terrace, Adelaide, SA 5000
Ethics committee country [1] 295826 0
Australia
Date submitted for ethics approval [1] 295826 0
09/08/2016
Approval date [1] 295826 0
28/08/2016
Ethics approval number [1] 295826 0
CALHN Ref R20160712, HREC Ref: HREC/16/RAH/269

Summary
Brief summary
Central hypertension leading to early vascular remodelling is an independent predictor of major cardiovascular events. Aorta is not only a conduit artery but also act as a vascular buffer to each ventricle contraction. Overtime, this stretch leads to decrease aortic compliance resulting in aortic stiffness. Ageing and HTN are the predominant attributable risk factors leading to premature aortic stiffness.
Central HTN can be computed by pulse wave morphology or velocity assessment. Central pressure indices including systolic, diastolic, pulse and augmented pressure along with augmentation index can be derived by central pulse wave morphology. Although evaluation of central haemodynamics can potentially flag the early phase of vascular remodelling but the precise component of central pressure indices predicting risk as per age is under considerable debate. Aortic stiffness is recognised as a surrogate for central arterial hypertension and its non-invasive estimation by pulse wave velocity (PWV) is considered “gold standard” by European Society of Cardiology (ESC) 2013 guidelines. Non-invasive central pulse wave morphology and velocity assessment is not being validated during atrial fibrillation (AF) . In addition, there is paucity of data revealing central pressure indices, including PWV appraisal as an independent predictor of outcome in AF.
1 Purpose of the study
Raised central pressure is more closely associated with cardiovascular outcome as compare to peripheral HTN. There is evolving evidence that central HTN is underdiagnosed leading to inadequate treatment resulting in early vascular ageing. We propose a staged prospective investigation by designing two perspective studies to validate and incorporate central pressure indices (central systolic, diastolic and pulse pressure with augmentation index and PWV) respectively in AF risk stratification with a view to titrate treatment as per central pressure to study clinical outcome in AF.

2 Aims
In this validation study we will compare invasive versus non-invasive central pressure indices appraisal including pulse wave morphology and velocity assessment in AF.
Through this study we seek:
I. To validate widely used non-invasive methods to assess local, regional and systemic central pressure indices while the subjects are in atrial fibrillation (AF). We will compare the non-invasive appraisal of central pressure with an invasive enumeration in our paroxysmal/persistent atrial fibrillation (PAF) cohort in atrial fibrillation and post restoration of sinus rhythm during elective pulmonary vein isolation (PVI).
II. We will review the shift in central pressure profile with rhythm control in our PAF cohort to identify the early changes in central pulsatile load as well as conduit artery compliance with restoration of sinus rhythm. and will draw a comparison between invasive and non-invasive evaluation
Trial website
Trial related presentations / publications
Abstract presentations at APHRS and CSANZ 2018 annual scientific meetings.
Public notes

Contacts
Principal investigator
Name 68634 0
Prof Prashanthan Sanders
Address 68634 0
CHRD, Dept. of Cardiology, Level 5, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country 68634 0
Australia
Phone 68634 0
+61882222723
Fax 68634 0
Email 68634 0
[email protected]
Contact person for public queries
Name 68635 0
Prashanthan Sanders
Address 68635 0
CHRD, Dept. of Cardiology, Level 5, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country 68635 0
Australia
Phone 68635 0
+61882222723
Fax 68635 0
Email 68635 0
[email protected]
Contact person for scientific queries
Name 68636 0
Prashanthan Sanders
Address 68636 0
CHRD, Dept. of Cardiology, Level 5, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country 68636 0
Australia
Phone 68636 0
+61882222723
Fax 68636 0
Email 68636 0
[email protected]

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