Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000646741
Ethics application status
Approved
Date submitted
17/06/2021
Date registered
3/05/2022
Date last updated
3/05/2022
Date data sharing statement initially provided
3/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preventing Heart Disease in Women with Non Traditional Risk Factors.
Scientific title
Preventing Heart Disease in Women with Non Traditional Cardiovascular Risk factors
Secondary ID [1] 304408 0
ERM ref No 61051
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular health 322202 0
Gestational Diabetes 323720 0
Pre-eclampsia 323721 0
Gestational Hypertension 323722 0
Small for Gestational age babies 323723 0
Placental Abruption 323724 0
Condition category
Condition code
Cardiovascular 319894 319894 0 0
Coronary heart disease
Diet and Nutrition 321252 321252 0 0
Obesity
Reproductive Health and Childbirth 321253 321253 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants receive 2 consultations with a Cardiologist & Cardiac Nurse RN. Interventions include physical examination, Observations BP, Hrt rate, height, Weight, waist & hip circumference.
Information is gained through questionnaires on diet & lifestyle & social economic factors. Health education is provided and depending on risks identified at the consultation a dietitian referral may be sort. Health education information leaflets and online links will be provided to participants at the consultations from the Australian Heart foundation and the Baker ID Institute. Covering diet management, lowering cholesterol, Managing blood sugars, weight loss, exercise & smoking cessation. Pathology is also required at each of three visits. Other interventions may be required based on normal care depending on the outcome or findings from the consultation this may include but is not limited to an ECG, BP, waist and hip circumference 24hr ABP if required. The duration of the visits are 50 mins- 1hr. An initial consult followed by a follow up consult at 6 months taking 45 mins. These are both face- face consultations. The patients with highlighted risks will be followed up separately with the Cardiologists as part of normal care as required. They may also receive continuous Cardiology follow up after the study has completed as deemed necessary by the Cardiologist as part of normal care and disease management.
Consultations provided to participants by both the Cardiologist and the Cardiac nurse are part of normal care if the participants were referred by their GP for cardiac review. However, the majority of participants would not normally be referred by their GP as they are young women and their GP may not have followed up on monitoring their Blood pressure or pathology for some time post their Gestational diabetes or Pre eclampsia. The study will answer the question as to how many women who have these risk factors have undiagnosed diabetes type 2 and/or undiagnosed hypertension.
Intervention code [1] 321783 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327769 0
Primary outcome measures will be any change in detection & Medical Treatment of traditional Cardiovascular disease risk factors.
Such as Objectively measured improvements in Blood Pressure using a sphygmomanometer.
Timepoint [1] 327769 0
Baseline & 6 months follow up visit
Primary outcome [2] 330076 0
Change in lipid levels assessed through pathology
Timepoint [2] 330076 0
Baseline & 6 month follow up visit
Primary outcome [3] 330077 0
Change in mean body weight assessed using digital scales.
Timepoint [3] 330077 0
Baseline & 6 months follow up visit
Secondary outcome [1] 396526 0
Co primary endpoints: Compared from baseline to study end:
1. Proportion of women who meet recommended Blood Pressure targets of <140/90 mmHg & <130/80mmHg ( id diabetic or impaired glucose tolerance)
Timepoint [1] 396526 0
Baseline & 6 months follow up visit
Secondary outcome [2] 402792 0
2.Proportion of women meeting recommended lipid targets of TC,HDL-C ratio<4.5mmol/L
Timepoint [2] 402792 0
Baseline & 6 months follow up visit
Secondary outcome [3] 404811 0
Client satisfaction, client acceptability survey.
Using a Patient Satisfaction Questionnaire Short Form (PSQ-18),
Timepoint [3] 404811 0
Baseline & 6 month follow up visit

Eligibility
Key inclusion criteria
Women ages between 30-55 years
With a past obstetric history of either gestational diabetes, pre eclampsia, gestational hypertension, small for gestational age baby or placental abruption.
Minimum age
30 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Known cardiovascular disease, unstable medical conditions that would preclude diet and exercise participation, cognitive impairment. Women who are currently pregnant or breast feeding (Within 12 months prior to study participation) or planning a pregnancy within the preceding 12 month study period.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analysis will be conducted by statisticians review of the all data collected on the RECAP database. The sample size of 150 women participants is based on the Framingham heart study cardiovascular risk score. Associated risk factors are well validated in the predication of future Cardiovascular events based on heart foundation statistics.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
25/05/2021
Date of last participant enrolment
Anticipated
Actual
21/04/2022
Date of last data collection
Anticipated
28/11/2022
Actual
Sample size
Target
150
Accrual to date
Final
156
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19630 0
The Alfred - Melbourne
Recruitment hospital [2] 19631 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [3] 19632 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 34263 0
3004 - Melbourne
Recruitment postcode(s) [2] 34264 0
3144 - Malvern
Recruitment postcode(s) [3] 34265 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 308775 0
University
Name [1] 308775 0
Monash University Partners Grant
Country [1] 308775 0
Australia
Primary sponsor type
University
Name
Monash University Partners
Address
Monash University
Monash Partners
level 1
43-51 Kannooka Grove
Clayton
VIC 3168
Country
Australia
Secondary sponsor category [1] 309684 0
None
Name [1] 309684 0
Address [1] 309684 0
Country [1] 309684 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308689 0
Monash Health
Ethics committee address [1] 308689 0
Ethics committee country [1] 308689 0
Australia
Date submitted for ethics approval [1] 308689 0
15/01/2020
Approval date [1] 308689 0
31/01/2020
Ethics approval number [1] 308689 0
RES 19-0000-681A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111566 0
A/Prof Sarah Zaman
Address 111566 0

Monash Health-Faculty medicine, nursing, health science/Monash Heart
Monash Medical Centre,246 Clayton Rd, Clayton, VIC 3168
Country 111566 0
Australia
Phone 111566 0
+61 1300643278
Fax 111566 0
Email 111566 0
sarah.zaman@monashhealth.org
Contact person for public queries
Name 111567 0
Sarah Zaman
Address 111567 0

Monash Health-Faculty medicine, nursing, health science/Monash Heart
Monash Medical Centre,246 Clayton Rd,
Clayton, VIC 3168
Country 111567 0
Australia
Phone 111567 0
+61 1300643278
Fax 111567 0
Email 111567 0
sarah.zaman@sydney.edu.au
Contact person for scientific queries
Name 111568 0
Caroline Steer
Address 111568 0
Monash University/ Monash Health-Faculty medicine, nursing, health science/Monash Heart
Monash Medical Centre,246 Clayton Rd, Clayton, VIC 3168
Country 111568 0
Australia
Phone 111568 0
+61 0466511865
Fax 111568 0
Email 111568 0
caroline.steer@monash.edu

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 primary outcome data
When will data be available (start and end dates)?
Data will be for 12 months at the end of the study until Dec 2023
Available to whom?
Anyone who wishes to access the information
Available for what types of analyses?
Primary data statistical analysis will be done through Monash university. Further data analysis can be requested through the Principle Investigator.
How or where can data be obtained?
Data will be available for any additional analysis on a case by case basis reviewed by the Principle investigator.
email: sarah.zaman@monashuniversity.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12116Informed consent form  med.womensheartstudy@monash.edu 382127-(Uploaded-21-09-2021-18-31-35)-Study-related document.pdf
12117Ethical approval  med.womensheartstudy@monash.edu



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePrevention of Cardiovascular Disease in Women With Pregnancy-Related Risk Factors: A Prospective Women's Heart Clinic Study.2023https://dx.doi.org/10.1161/JAHA.123.030015
N.B. These documents automatically identified may not have been verified by the study sponsor.