Celebrating International Clinical Trials day

Published: Wednesday 20th May 2015

Thursday 20 May was international Clinical Trials Day and a time to highlight the importance of high quality clinical trials to develop robust and cost-effective ways (from pharmacological agents to health service interventions) to address our most pressing health issues.

Researchers from ACU’s Mary MacKillop Institute for Health Research can proudly reflect on their recent an ongoing contribution to developing innovative health services for those affected by Australia’s most prevalent, costly and disabling health issue – cardiovascular disease.

Below is a summary of some of the major trials that are being led or have been recently reported by senior researchers within the Institute.

These randomised controlled trials span the continuum from primary prevention to chronic disease management and all are designed to influence public health policy, clinical guidelines and health care service planning.

The quality and impact of these trials is reflected in many ways – a) predominance of peer-review (NHMRC) funding support, b) presentation as “hot-line/late-breaking trials” at prestigious international conferences, c) international awards for research excellence, d) publication in high-impact journals and e) accompanying editorials.

Primary Prevention Trials (NHMRC funding $2.5+ million & Commercial funding $7million)

Near to completion, the IMPRESS Study (led by A/Professor Melinda Carrington and funded by an NHMRC Program Grant) is examining the impact of nurse-led primary prevention of sub-clinical atherosclerosis (the primary cause of heart attack and strokes) in individuals with low inherent risk but a family history of premature cardiovascular disease). Focussing on high risk individuals with pre-diabetes/metabolic syndrome living in regional Australia, the MODERN Study (led by A/Professor Melinda Carrington and funded by an NHMRC Project Grant) is testing the impact of nurse-led clinics established in Shepparton and Colac in regional Victoria. The study intervention aims to reduce the risk of progression to diabetes and often disabling and fatal cardiovascular events in the future. A major contributor to the design and focus of these trials is the commercially sponsored VIPER-BP Study (led by Professor Simon Stewart), that represented Australia’s largest ever study of hypertension management in primary care. Results from the trial were reported in the prestigious British Medical Journal.[1]

Secondary Prevention Trials (NHMRC funding $3+ million & Commercial funding $1+ million)

With follow-up due to be completed at the end of this year, the Central Australia Heart Protection Study (co-led by A/Professor Melinda Carrington and funded by an NHMRC Project Grant) is examining the potential benefits of a nurse-led, family-based, outreach program for Indigenous and non-Indigenous patients admitted to Alice Springs Hospital with an acute coronary syndrome. Representing an arduous intervention (with face-to-face visits requiring hundreds of kilometres driving), it addresses particularly poor cardiac outcomes in the Indigenous communities of Central Australia. This study builds on two similar secondary prevention programs tested in two very different patient populations. The Young @ Heart Study (led by Professor Simon Stewart with commercial funding) examined a home-based, nurse-led program of follow-up (2-years) in privately insured patients admitted to two Queensland hospitals with heart disease (predominantly coronary artery disease). As reported in the prestigious Circulation: Cardiovascular Quality and Outcomes there were benefits for men, but now women in terms of reduced hospital stay relative to standard, private care; leaving the residual question whether this form of intervention works in a privately insured setting.[2] In contrast, the recently reported NIL-CHF Study (led by Professor Simon Stewart and funded by an NHMRC Project Grant) provides clear evidence that this type of secondary prevention is beneficial in the public setting (even within a background of specialist cardiac care and follow-up). As very recently reported in the world’s top heart failure journal, the European Journal of Heart Failure, a hybrid nurse-led program of home and clinic-based follow-up over 3 years, was associated with significant cardio-protection (as measured by serial echocardiography) and reduced hospital stay relative to standard care.[3]

Chronic Disease Management Trials (NHMRC funding $4+ million)

In a landmark report in one of the world’s most prestigious and influential journals (The Lancet), the results of the SAFETY Trial (led by Professor Simon Stewart and funded via a NHMRC Program Grant) showed (as a world-first) that nurse-led, multidisciplinary, atrial fibrillation-specific management is superior to standard care in prolonging survival and reducing recurrent hospital stay in those hospitalised with a chronic form of this condition.[4] This trial builds on the previous, seminal work of MacKillop researchers in establishing the utility of heart failure management programs to achieve the same in those affected by this deadly and disabling syndrome. More recently, the group reported on the WHICH? Trial (led by Professor Simon Stewart and funded via a NHMRC Health Service Grant) that demonstrated that heart failure management applied in the home is superior to that applied via specialist clinics in reducing hospital stay and prolonging survival; reported in two of the world’s most prestigious cardiology journals – Journal of the American College of Cardiology and International Journal of Cardiology.[5,6] This has led to a follow-up study (the WHICH? II Trial also led by Professor Simon Stewart and funded via a NHMRC Project Grant) examining the cost-benefits of a hybrid (face-to-face and structured telephone support) and individualised management program relative to standard care. 

Future Trials

Institute Director, Professor Simon Stewart, is happy to report that the MacKillop continues to invest in its capacity to undertake ground-breaking trials with strong translational potential. Plans for a major trial in the primary care management of heart failure (supported by commercial investment) and an international, multicentre trial of multimorbidity in heart failure (supported by the National Institutes of Health in the USA) are well underway.

The Institute has a dedicated data management and coordinating centre and a national and international network of collaborating organisations and individuals to facilitate its research and looks forward to maintaining a strong pipeline of trials that meets the Institute’s mantra – “never see a need without doing something about it”.