Khalil Anchouche1, Malik Elharram1, Emily Oulousian1, Amir Razaghizad1, Robert Avram2, Guillaume Marquis-Gravel3, Varinder Kaur Randhawa4, Richard Nkulikiyinka5, Wei Ni6, Mona Fiuzat7, Christopher O'Connor8, Mitchell A Psotka9, Jonathan Fox10, Benoit Tyl11, David Kao12, Abhinav Sharma13. 1. Division of Cardiology, McGill University Health Centre, McGill University, Montréal, Québec, Canada; DREAM-CV Lab, McGill University Health Centre, McGill University, Montréal, Québec, Canada. 2. Division of Cardiology, Department of Medicine, Ottawa Heart Institute, University of Ottawa, Ottawa, Ontario, Canada; Division of Cardiology, University of California San Francisco, San Francisco, California, USA; Montréal Heart Institute, Université de Montréal, Montréal, Québec, Canada. 3. Montréal Heart Institute, Université de Montréal, Montréal, Québec, Canada. 4. Department of Cardiovascular Medicine, Kaufman Center for Heart Failure, Heart, Vascular and Thoracic Institute, Cleveland, Ohio, USA. 5. Research and Development, Pharmaceuticals, Bayer, Wuppertal, Germany. 6. Eli Lilly and Company, Indianapolis, Indiana, USA. 7. Division of Cardiology, Duke University, Durham, North Carolina, USA. 8. Division of Cardiology, Duke University, Durham, North Carolina, USA; Inova Heart and Vascular Institute, Falls Church, Virginia, USA. 9. Inova Heart and Vascular Institute, Falls Church, Virginia, USA. 10. Eidos Therapeutics, San Francisco, California, USA. 11. Center for Therapeutic Innovation Cardiovascular and Metabolic diseases, Institut de Recherches Internationales Servier, Suresnes, France. 12. Department of Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA. 13. Division of Cardiology, McGill University Health Centre, McGill University, Montréal, Québec, Canada; DREAM-CV Lab, McGill University Health Centre, McGill University, Montréal, Québec, Canada. Electronic address: Abhinav.sharma@mcgill.ca.
Abstract
BACKGROUND: Actigraphy-based measurements of physiologic parameters may enable design of patient-centric heart failure (HF) clinical trials. Recently, the Heart Failure Collaboratory focused on recommendations for meaningful change and use of actigraphy as an end point in HF clinical trials. We aimed to evaluate randomized controlled trials (RCTs) that have quantified the impact of HF interventions using actigraphy. METHODS: Using a scoping review strategy, we evaluated the use of actigraphy in HF RCTs. Studies were identified through electronic searches of Embase, OVID Medline, PubMed, and Cochrane Review. Data on trial characteristics and results were collected. RESULTS: We identified 11 RCTs with a total of 1,455 participants. The risk of bias across the included trials was high overall. All trials had the primary outcomes reflecting measures of either physical activity (n = 8), sleep (n = 2), or both (n = 1). Five trials evaluated response to pharmacologic therapies compared with placebo, 3 evaluated physical activity interventions, 2 evaluated group or cognitive therapy, and 1 evaluated sleep-ventilation strategy. Sample sizes ranged from 30 to 619 participants. There was significant heterogeneity relating to device type, body placement site, and handling of missing actigraphy data. Duration of monitoring ranged from 48 hours to 12 weeks. None of the studies evaluating pharmacologic therapies (n = 5) demonstrated a significant improvement of actigraphy-based primary end point measurements. CONCLUSIONS: There is significant heterogeneity in the use, methodology, and results of actigraphy-based HF RCTs. Our results highlight the need to develop, standardize, and validate actigraphy-specific outcomes for use in HF clinical trials.
BACKGROUND: Actigraphy-based measurements of physiologic parameters may enable design of patient-centric heart failure (HF) clinical trials. Recently, the Heart Failure Collaboratory focused on recommendations for meaningful change and use of actigraphy as an end point in HF clinical trials. We aimed to evaluate randomized controlled trials (RCTs) that have quantified the impact of HF interventions using actigraphy. METHODS: Using a scoping review strategy, we evaluated the use of actigraphy in HF RCTs. Studies were identified through electronic searches of Embase, OVID Medline, PubMed, and Cochrane Review. Data on trial characteristics and results were collected. RESULTS: We identified 11 RCTs with a total of 1,455 participants. The risk of bias across the included trials was high overall. All trials had the primary outcomes reflecting measures of either physical activity (n = 8), sleep (n = 2), or both (n = 1). Five trials evaluated response to pharmacologic therapies compared with placebo, 3 evaluated physical activity interventions, 2 evaluated group or cognitive therapy, and 1 evaluated sleep-ventilation strategy. Sample sizes ranged from 30 to 619 participants. There was significant heterogeneity relating to device type, body placement site, and handling of missing actigraphy data. Duration of monitoring ranged from 48 hours to 12 weeks. None of the studies evaluating pharmacologic therapies (n = 5) demonstrated a significant improvement of actigraphy-based primary end point measurements. CONCLUSIONS: There is significant heterogeneity in the use, methodology, and results of actigraphy-based HF RCTs. Our results highlight the need to develop, standardize, and validate actigraphy-specific outcomes for use in HF clinical trials.
Authors: Sanchit Kumar; Angela M Victoria-Castro; Hannah Melchinger; Kyle D O'Connor; Mitchell Psotka; Nihar R Desai; Tariq Ahmad; F Perry Wilson Journal: J Cardiovasc Transl Res Date: 2022-09-09 Impact factor: 3.216
Authors: Byoungjun Kim; Wendy M Troxel; Tamara Dubowitz; Gerald P Hunter; Bonnie Ghosh-Dastidar; Basile Chaix; Kara E Rudolph; Christopher N Morrison; Charles C Branas; Dustin T Duncan Journal: Sleep Date: 2022-08-11 Impact factor: 6.313