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Protocol for the WARM Hearts study: examining cardiovascular disease risk in middle-aged and older women - a
Alexandra V Rose1,2, Kevin F Boreskie1,2,3, Jacqueline L Hay1,2
1Faculty of Kinesiology and Recreation Management, University of Manitoba, Winnipeg, Manitoba, Canada.
Insights
The WARM Hearts study is developing new ways to detect cardiovascular disease (CVD) risk in women over 55. By combining physical assessments and novel biomarkers, this research aims to improve early identification and prevention strategies for women's heart health.
Area of Science:
- Cardiology
- Women's Health
- Preventive Medicine
Background:
- Cardiovascular disease (CVD) is a primary cause of mortality in women, necessitating improved early detection methods.
- Current CVD risk assessment tools may not fully capture the unique risk profiles of women.
- There is a need for novel approaches integrating physical function and biomarkers for enhanced risk stratification.
Purpose of the Study:
- To investigate the efficacy of novel non-invasive assessments and biomarkers in identifying women at elevated risk for adverse cardiovascular events.
- To enhance traditional cardiovascular risk assessment by incorporating physical function and frailty measures.
- To compare the predictive accuracy of the WARM Hearts approach against the established Framingham Risk Score.
Main Methods:
- The Women's Advanced Risk-assessment in Manitoba (WARM) Hearts study is a prospective, observational cohort study.
- Recruitment of 1000 women aged 55+ for two screening appointments including comprehensive assessments (medical history, physical function, cognition, biomarkers, gut microbiota).
- Longitudinal assessment of adverse cardiovascular outcomes over 5 years post-screening.
Main Results:
- This section is to be filled once the study is completed and results are available.
Conclusions:
- This section is to be filled once the study is completed and conclusions are drawn.
Introduction:
Cardiovascular disease (CVD) is a leading cause of death in women. Novel approaches to detect early signs of elevated CVD risk in women are needed. Enhancement of traditional CVD risk assessment approaches through the addition of procedures to assess physical function or frailty as well as novel biomarkers of cardiovascular, gut and muscle health could improve early identification. The Women's Advanced Risk-assessment in Manitoba (WARM) Hearts study will examine the use of novel non-invasive assessments and biomarkers to identify women who are at elevated risk for adverse cardiovascular events.
Methods And Analysis:
One thousand women 55 years of age or older will be recruited and screened by the WARM Hearts observational, cohort study. The two screening appointments will include assessments of medical history, gender variables, body composition, cognition, frailty status, functional fitness, physical activity levels, nutritional status, quality of life questionnaires, sleep behaviour, resting blood pressure (BP), BP response to moderate-intensity exercise, a non-invasive measure of arterial stiffness and heart rate variability. Blood sample analysis will be used to assess lipid and novel biomarker profiles and stool samples will support the characterisation of gut microbiota. The incidence of the adverse cardiovascular outcomes will be assessed 5 years after screening to compare WARM Hearts approaches to the Framingham Risk Score, the current clinical standard of assessing CVD risk in Canada.
Ethics And Dissemination:
The University of Manitoba Health Research Ethics Board (7 October 2019) and the St Boniface Hospital Research Review Committee (7 October 2019) approved the trial (Ethics Number HS22576 (H2019:063)). Recruitment started 10 October 2020. Data gathered from the WARM Hearts study will be published in peer-reviewed journals and presented at national and international conferences. Knowledge translation strategies will be created to share our findings with stakeholders who are positioned to implement evidence-informed CVD risk assessment programming.
Trial Registration Number:
NCT03938155.
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