Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000548538p
Ethics application status
Submitted, not yet approved
Date submitted
16/04/2024
Date registered
1/05/2024
Date last updated
1/05/2024
Date data sharing statement initially provided
1/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Handgrip echocardiography for the detection of early signs of heart dysfunction in women after preeclampsia
Scientific title
Isometric handgrip echocardiography for detection of early diastolic dysfunction in women after preeclampsia
Secondary ID [1] 311926 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preeclampsia 333512 0
Diastolic dysfunction 333625 0
Condition category
Condition code
Cardiovascular 330193 330193 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is isometric handgrip exercise for 2-3 minutes duration at 30-40% of a participants' maximal handgrip strength during echocardiography.

A cardiologist and/or trained research team member will perform the assessment.
Resting echocardiography will be conducted first and will provide an overall indication of resting cardiac structure and diastolic function (~20 minutes). Resting measures will precede handgrip measures so the effects of exercise do not influence these resting results, which is standard practice for stress echocardiography. This will be followed by a 5-minute wash-out/ rest period prior to performing the isometric handgrip echocardiography. Isometric handgrip echocardiography will involve 2-3 minutes of isometric handgrip exercise, assessed using a dynamometer, and utilising a combination of visual feedback to participants and auditory encouragement from researchers to ensure compliance with the protocol to maintain an intensity between 30-40% of a participant's maximum grip strength. This will be performed unilaterally with the right arm. Echocardiography prioritising diastolic assessment will occur during the final minute of exercise and again immediately post exercise.
Intervention code [1] 328389 0
Early detection / Screening
Comparator / control treatment
Resting echocardiography (no handgrip exercise during echocardiographic examination, commonly used in assessments).
Control group
Active

Outcomes
Primary outcome [1] 337944 0
Left ventricular diastolic function
Timepoint [1] 337944 0
Resting (imaging taken during the preceding resting echocardiography ~20 minutes), peak exercise (primary timepoint, minute 2-3 of exercise), post exercise (immediately upon the cessation of exercise ~ 3 minutes).
Primary outcome [2] 338102 0
Left ventricular twist mechanics
Timepoint [2] 338102 0
Resting (imaging taken during the preceding resting echocardiography ~20 minutes), peak exercise (primary timepoint, minute 2-3 of exercise), post exercise (immediately upon the cessation of exercise ~ 3-5 minutes).
Primary outcome [3] 338103 0
Global longitudinal strain
Timepoint [3] 338103 0
Resting (imaging taken during the preceding resting echocardiography ~20 minutes), peak exercise (primary timepoint, minute 2-3 of exercise), post exercise (immediately upon the cessation of exercise ~ 3-5 minutes).
Secondary outcome [1] 433828 0
Blood pressure
Timepoint [1] 433828 0
Continuously during the pre-exercise (5 minutes), during exercise (2-3 minutes), post exercise (5 minutes) periods
Secondary outcome [2] 433829 0
Cardiac output
Timepoint [2] 433829 0
Continuously during the pre-exercise (5 minutes), during exercise (2-3 minutes), post exercise (5 minutes) periods
Secondary outcome [3] 433830 0
Total peripheral vascular resistance
Timepoint [3] 433830 0
Continuously during the pre-exercise (5 minutes), during exercise (2-3 minutes), post exercise (5 minutes) periods
Secondary outcome [4] 434064 0
Heart rate
Timepoint [4] 434064 0
Continuously during the pre-exercise (5 minutes), during exercise (2-3 minutes), post exercise (5 minutes) periods

Eligibility
Key inclusion criteria
Must have had a previous pregnancy with preeclampsia at least 6 months prior and not more than 7 years prior to the assessment session.
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosed heart failure, congenital heart disease, or cardiovascular disease, other than hypertension
- Medications that can significantly alter cardiac function
- Diagnosed pulmonary arterial hypertension, or pulmonary embolism
- Inability to perform handgrip exercise
- Inability to provide written, informed consent in English.

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/05/2024
Actual
Date of last participant enrolment
Anticipated
25/11/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316271 0
Charities/Societies/Foundations
Name [1] 316271 0
Women and Infants Research Foundation
Country [1] 316271 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Country
Australia
Secondary sponsor category [1] 318460 0
None
Name [1] 318460 0
Address [1] 318460 0
Country [1] 318460 0
Other collaborator category [1] 283002 0
Hospital
Name [1] 283002 0
Fiona Stanley Hospital
Address [1] 283002 0
Country [1] 283002 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315091 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 315091 0
https://smhs.health.wa.gov.au/Our-research/For-researchers
Ethics committee country [1] 315091 0
Australia
Date submitted for ethics approval [1] 315091 0
28/02/2024
Approval date [1] 315091 0
Ethics approval number [1] 315091 0
RGS0000006707

Summary
Brief summary
Preeclampsia and hypertensive disorders of pregnancy are associated with a significant increase in the risk of developing early onset cardiovascular diseases, including heart failure. This project is investigating the ability for isometric handgrip echocardiography to detect early signs of diastolic dysfunction in the heart, prior to changes being observed by traditional resting echocardiography and clinical signs of heart failure. This may facilitate future studies into early intervention in this population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133646 0
Prof Luke Haseler
Address 133646 0
School of Allied Health, Curtin University, GPO Box U1987, Perth Western Australia, 6845
Country 133646 0
Australia
Phone 133646 0
+61 08 9266 3634
Fax 133646 0
Email 133646 0
Luke.Haseler@curtin.edu.au
Contact person for public queries
Name 133647 0
Anna Scheer
Address 133647 0
School of Allied Health, Curtin University, GPO Box U1987, Perth Western Australia, 6845
Country 133647 0
Australia
Phone 133647 0
+61452236661
Fax 133647 0
Email 133647 0
anna.s.scheer@curtin.edu.au
Contact person for scientific queries
Name 133648 0
Anna Scheer
Address 133648 0
School of Allied Health, Curtin University, GPO Box U1987, Perth Western Australia, 6845
Country 133648 0
Australia
Phone 133648 0
+61452236661
Fax 133648 0
Email 133648 0
anna.s.scheer@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant outcome data (numerical only, not image files) will be available for participants who have separately consented to this (per current ethical approval), upon reasonable request, if meeting the conditions outlined below.
When will data be available (start and end dates)?
After publication of the project data has occurred and will be available for 7 years from the date of project conclusion.
Available to whom?
To researchers from Curtin University and Fiona Stanley Hospital conducting related research that has ethical approval. Please contact authors for research collaboration opportunities.
Available for what types of analyses?
Related research that has ethical approval investigating isometric handgrip echocardiography, or projects investigating cardiac health in women who have had preeclampsia.
How or where can data be obtained?
Through contacting members of the research team (PI Luke.Haseler@curtin.edu.au, AI anna.s.scheer@curtin.edu.au).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22151Study protocol  luke.haseler@curtin.edu.au Alternate email anna.s.scheer@curtin.edu.au



Results publications and other study-related documents

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