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
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
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
[email protected]
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
[email protected]
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
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• To researchers from Curtin University and Fiona Stanley Hospital conducting related research that has ethical approval. Please contact authors for research collaboration opportunities.

Conditions for requesting access:
• -

What individual participant data might 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.

What types of analyses could be done with individual participant data?
• Related research that has ethical approval investigating isometric handgrip echocardiography, or projects investigating cardiac health in women who have had preeclampsia.

When can requests for individual participant data be made (start and end dates)?
From:
After publication of the project data has occurred and will be available for 7 years from the date of project conclusion.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Through contacting members of the research team (PI [email protected], AI [email protected]).

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22151Study protocol  [email protected] Alternate email [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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