FRAIL-AS Response Trial

Frailty response in patients with aortic stenosis undergoing transcatheter aortic valve implantation: a pilot, cluster-randomised controlled trial.

Led by Dr Nicola Straiton, Professor Sandy Middleton, Professor David Muller, Professor Peter MacDonald and Professor Elizabeth McInnes, the FRAIL-AS Response Trial commenced in February 2024.

Background 

Aortic stenosis, which affects 1 in 8 older adults, narrows the heart valve and causes symptoms of breathlessness, chest pain, and heart failure. Traditional treatment is open-heart surgery, but since 2002 a less invasive procedure called transcatheter aortic valve implantation (TAVI) has become an alternative, especially for frail patients with aortic stenosis. Frailty is present in 3 out of 10 people who undergo TAVI. However, there is limited evidence on managing frailty in patients with aortic stenosis, leading to poorer outcomes after TAVI procedures.

Aim

This co-designed research aims to examine the feasibility of implementing a Frailty Response Program intervention for frail patients with aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). The aspiration of the research team is to close the gap between identifying frailty in patients with aortic stenosis undergoing TAVI and implementing evidence-based frailty management practices, to ultimately improve patient outcomes and enhance care quality.

Design

Using a cluster-randomised controlled trial design, the study will compare the Frailty Response Program intervention to standard care in ten Australian hospitals. This multicomponent, comprehensive program includes a nutritional assessment, geriatrician review, rehabilitation referrals, continuity of care, and patient education, all tailored to the patient’s frailty status. The Frailty Response Program will begin before the TAVI procedure and continue with follow-up for 12 months post-procedure.

Trial Collaborators

Nursing Research Institute

Dr Nicola Straiton, Senior Research Fellow

Professor Sandy Middleton, Director

Tessa Holman, Research Officer

Professor Elizabeth McInnes, Deputy Director

National Colleagues 

Professor David Muller (St Vincent’s Health Network Sydney and St Vincent’s Private Hospital, Sydney)

Professor Peter MacDonald (St Vincent’s Health Network Sydney and St Vincent’s Private Hospital, Sydney)

Dr David Roy (St Vincent’s Health Network Sydney and St Vincent’s Private Hospital, Sydney)

Dr Nicholas Mills (St Vincent’s Health Network Sydney and St Vincent’s Private Hospital, Sydney)

Alexis Arriagada (St Vincent’s Private Hospital Sydney, Sydney)

Professor Steve Frost (Western Sydney University)

Professor Sally Inglis (University of Technology Sydney)

Mallory Herrero (University of Technology Sydney)

Adjunct Professor Anna Thornton (Australian Commission on Safety and Quality in Health Care)

Dr Xenia Dolja-Gore (University of Newcastle)

Dr Victoria McCreanor (Hunter Medical Research Institute)

Sandra Harrison (The George Institute for Global Health)

Dr Julee McDonagh (University of Wollongong)

Professor Caleb Ferguson (University of Wollongong)

Dr Angela Wan (Monash University)

International Colleagues

Professor Sandra Lauck (University of British Columbia, Canada)

Karen Wilson (St Thomas’ Hospital, United Kindom)

Visit the pages below to learn about the FRAIL-AS Response Trial in more depth

Australian and New Zealand Clinical Trials Registry: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=387297

Acknowledgement:

We would like to acknowledge the valuable contribution of the consumers, nurses, doctors, allied health and others who are involved with our trial. Without their contribution, this trial would not have been possible.

Contact us:

If you would like to get in contact with us, please email: FRAILASRespTrial@acu.edu.au