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Preventing Heart Disease in Women with Non Traditional Risk Factors.

Preventing Heart Disease in Women with Non Traditional Cardiovascular Risk factors

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000646741
Enrollment
156
Registered
2022-05-03
Start date
2021-05-25
Completion date
2022-04-21
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 consu

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.

Sponsors

Monash University Partners
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
30 Years to 55 Years
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 31, 2026