Interventional - Procedure
DEFINIT-P is a pilot study that will determine the feasibility of a larger, multi-centre randomized clinical trial to evaluate the efficacy of a supervised exercise and nutritional supplement program in preventing or reversing frailty in cardiac device recipients.
The primary outcomes in this pilot will be:
1) the rate of identification of eligible patients
2) the proportion of eligible patients consenting to participate, and randomized
3) the rate of adherence to the trial interventions
(as measured by supervised exercise attendance rates, device-recorded physical activity levels, and direct question about nutritional supplement/placebo adherence)
4) the obstacles to and facilitators of adherence to the intervention
The secondary outcomes in this pilot will be:
1) frailty, as measured by the Fried index
2) clinical cardiovascular outcomes
(myocardial infarction, stroke, heart failure hospitalization, atrial fibrillation, ventricular tachyarrhythmia)
3) cardiac device complications (inappropriate defibrillator shocks, lead dislodgement)
4) injury from a fall or fracture.
Interventional - Procedure
Multi-centre RCT pilot
Darryl Leong is a Scientist at PHRI, Director of the McMaster University and Hamilton Health Sciences Cardio-Oncology Program, Associate Professor, Department of Medicine (Cardiology), McMaster University, and Staff Cardiologist at Hamilton Health Sciences. He has methodological expertise in clinical epidemiology and clinical trials, and content expertise in physical frailty, echocardiography, and cardio-oncology. His research is supported by the CIHR, and he has published more than 150 manuscripts including all the leading internal medical and cardiovascular journals.
He graduated from the University of Adelaide Medical School with Deans Listing and Honours for academic excellence, completed his cardiology training, Doctor of Philosophy, Master of Public Health, and Master of Biostatistics degrees at the University of Adelaide in Australia, and completed a post-doctorate fellowship in cardiovascular imaging at the Leiden University Medical Centre in The Netherlands, before re-locating to Canada.
Jeff Healey is a Senior Scientist in the Arrhythmia and Heart Failure research program at PHRI, an Associate Professor, Medicine, McMaster University, and Director of Arrhythmia Services at Hamilton Health Sciences. His research involves conducting RCTs and large registries in the fields of atrial fibrillation and cardiac devices. He was the lead author of the SIMPLE trial, published in the Lancet in 2015, which demonstrated that implantable defibrillators could be safely inserted without performing intra-operative defibrillation testing.
He was the lead author of the ASSERT trial, published in New England Journal of Medicine in 2012, demonstrating the increased stroke risk associated with sub-clinical atrial fibrillation detected by pacemakers. Thomson-Reuters recognized ASSERT as the 38th most-cited scientific publication in 2012 (#16 in Medicine).
He was principal investigator and chair of the Canadian Stroke Prevention Intervention Network (CSPIN), a ten-year network grant funded by the Canadian Institutes of Health Research, The Heart and Stroke Foundation of Canada and Industry. He is the past co-chair of the Canadian Cardiovascular Society’s Atrial Fibrillation Guidelines Committee. Jeff has published more than 185 manuscripts.
Jackie Bosch started working with Salim Yusuf in 1993, before PHRI was formally created, as she was completing her Masters in Clinical Epidemiology, with the intent to learn how to do clinical trials so she could run trials in post-stroke rehabilitation. Most recently, she has been a co-investigator on large trials in primary and secondary prevention of cardiovascular disease and diabetes, as well as understanding the causes of functional decline as well as developing simple, internationally applicable interventions to improve post-stroke disability.
She is Assistant Dean of the Occupational Therapy program, School of Rehabilitation Sciences, McMaster University, and has received awards such as the (McMaster) President’s Award for Outstanding Service, and the PHRI Award for Outstanding Contributions to Global Collaborations. She has more than 65 peer-reviewed publications.
Sumathy Rangarajan has been Program Director, Global Health, since 2016, preceded by many years’ service at PHRI in other roles. She oversees the PURE study team, as well as the INVICTUS rheumatic AF treatment trial, the CANPWR pediatric weight management registry, and others.
She holds both a Bachelor of Science Degree and a Master of Science degree from Pune University in India.
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