ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

ERM ref No 61051

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cardiovascular health

Gestational Diabetes

Pre-eclampsia

Gestational Hypertension

Small for Gestational age babies

Placental Abruption

Condition category

Condition code

Cardiovascular

Coronary heart disease

Diet and Nutrition

Obesity

Reproductive Health and Childbirth

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Baseline & 6 months follow up visit

Primary outcome [2]

Change in lipid levels assessed through pathology

Timepoint [2]

Baseline & 6 month follow up visit

Primary outcome [3]

Change in mean body weight assessed using digital scales.

Timepoint [3]

Baseline & 6 months follow up visit

Secondary outcome [1]

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]

Baseline & 6 months follow up visit

Secondary outcome [2]

2.Proportion of women meeting recommended lipid targets of TC,HDL-C ratio<4.5mmol/L

Timepoint [2]

Baseline & 6 months follow up visit

Secondary outcome [3]

Client satisfaction, client acceptability survey.
Using a Patient Satisfaction Questionnaire Short Form (PSQ-18),

Timepoint [3]

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]

The Alfred - Melbourne

Recruitment hospital [2]

Cabrini Hospital - Malvern - Malvern

Recruitment hospital [3]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

3004 - Melbourne

Recruitment postcode(s) [2]

3144 - Malvern

Recruitment postcode(s) [3]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University Partners Grant

Address [1]

Monash Partners
level 1
43-51 kannooka Grove
Clayton
VIC 3168

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health

Ethics committee address [1]

Monash Medical Centre 
Level 2, I Block
246 Clayton Road
Clayton
Victoria
3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/01/2020

Approval date [1]

31/01/2020

Ethics approval number [1]

RES 19-0000-681A

Summary

Brief summary

A 6 month Interventional study enrolling 150 women participants between the ages of 30-55 years. To evaluate  and assess the effectiveness of a Women only Heart Clinic in reducing Cardiovascular risk and improving cardiovascular outcomes.  The study reviews women with a > 1year past obstetric history of gestational diabetes, pre eclampsia, gestational hypertension, small for gestational age babies and placental abruption. The study is based on normal care offered to women with identified traditional CVD  risk factors as well as Non traditional risk factors.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Sarah Zaman

Address

Monash Health-Faculty medicine, nursing, health science/Monash Heart
Monash Medical Centre,246 Clayton Rd, Clayton, VIC 3168

Country

Australia

Phone

+61 1300643278

Fax

[email protected]

Contact person for public queries

Name

Sarah Zaman

Address

Monash Health-Faculty medicine, nursing, health science/Monash Heart
Monash Medical Centre,246 Clayton Rd,
Clayton, VIC 3168

Country

Australia

Phone

+61 1300643278

Fax

[email protected]

Contact person for scientific queries

Name

Caroline Steer

Address

Monash University/ Monash Health-Faculty medicine, nursing, health science/Monash Heart
Monash Medical Centre,246 Clayton Rd, Clayton, VIC 3168

Country

Australia

Phone

+61 0466511865

Fax

[email protected]

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: [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
12116	Informed consent form			[email protected]		382127-(Uploaded-21-09-2021-18-31-35)-Study-related document.pdf
12117	Ethical approval			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Prevention of Cardiovascular Disease in Women With Pregnancy-Related Risk Factors: A Prospective Women's Heart Clinic Study.	2023	https://dx.doi.org/10.1161/JAHA.123.030015

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically