Study Type
Interventional - Procedure
completed
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.
Study Design
Multi-centre RCT pilot
NO. of Countries
1
NO. of Sites
1
NO. of Participants
120
Study Period
2019-2020
Sponsor
PHRI
Darryl Leong
Senior Scientist
Darryl Leong
Senior Scientist
Leong’s clinical interests include cardio-oncology, frailty, multi-morbidity, and echocardiography. He is the Director of the McMaster University and Hamilton Health Sciences Cardio-Oncology Program. Leong graduated from the University of Adelaide Medical School with Deans Listing and Honours for academic excellence in 2000. He completed his cardiology training, Doctor of Philosophy, Master of Public Health, and Master of Biostatistics degrees at the University of Adelaide, Australia. He has completed a fellowship in cardiovascular imaging at the Leiden University Medical Centre, the Netherlands, before relocating to Canada.
Leong is an Associate Professor in the Division of Cardiology, Department of Medicine, at McMaster University and Hamilton Health Sciences. His research is supported by the Canadian Institutes of Health Research, Canadian Cancer Society, and the United States Department of Defense, among others. He has published approximately 200 manuscripts, including leading publications in the Lancet and New England Journal of Medicine as well as top cardiovascular journals. He is a Clinician Scientist of the Heart and Stroke Foundation of Canada and has received the Clive Kearon Mid-Career Award from McMaster University. Additionally, he serves as the Director of the Internal Medicine Resident Research Program and the Cardio-Oncology Program at McMaster University.
Jeff Healey
Senior Scientist
Jeff Healey
Senior Scientist
Jeff Healey is a Cardiologist/Electrophysiologist and Professor of Medicine at McMaster University. He is Yusuf Chair and Director of Cardiology at McMaster University. He is the chair of the Canadian Stroke Prevention and Intervention Network (CSPIN) and past chair of the Canadian Atrial Fibrillation guidelines committee. He is also on the steering committee of the international AF Screen organization.
Healey was the lead author of the ASSERT trial that demonstrated the increased stroke risk associated with sub-clinical atrial fibrillation (New England Journal of Medicine 2012), and the principal investigator of the ARTESIA trial, which demonstrated that anticoagulation with apixaban reduced the risk of stroke in patients with sub-clinical atrial fibrillation New England Journal of Medicine 2023). He is also the principal investigator of the LAAOS-4 trial, evaluating the role of left atrial appendage occlusion on top of NOAC therapy for prevention of stroke in high-risk individuals with atrial fibrillation.
Jackie Bosch
Scientist
Jackie Bosch
Scientist
Jackie Bosch is the Assistant Dean of the McMaster Occupational Therapy Program and a PHRI Scientist. She has a Bachelor’s degree in Occupational Therapy, a Master’s degree in Clinical Epidemiology and Biostatistics, and a PhD in Rehabilitation Science. She also serves as a Professor in the School of Rehabilitation and has an Adjunct Appointment with the University of Galway College of Medicine, Nursing, and Health Sciences.
Her research focuses on improving functional outcomes in clinical trials, particularly for stroke survivors in low-resource settings, and enhancing clinical trial methods. Bosch has taken on leadership roles in large-scale trials such as HOPE, HOPE-TOO, HOPE-3 (NCT00468923), DREAM (NCT00095654), ORIGIN (NCT00069784), TIPS-3 (NCT01646437), and COMPASS (NCT01776424). She leads the Organized Stroke Care Across Income Levels (OSCAIL) group, which has conducted a proof-of-concept study implementing key aspects of stroke unit care in hospitals within low-resource settings. Currently, the OSCAIL group is working on a community-based study aimed at improving outcomes for stroke survivors in these challenging environments. Bosch is also interested in optimizing how clinical trials are conducted, especially by finding new ways to make the start-up and execution processes more efficient.
Jackie Bosch has published 184 articles and received several awards, including the Lorna Reimer Award for Leadership from the Canadian Occupational Therapy Foundation in 2019 and the Faculty of Health Sciences, McMaster University, Programs Award for Graduate Students in 2014.
Sumathy Rangarajan
Program Director
Sumathy Rangarajan
Program Director
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.
