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Multicenter Study
. 2023 Jun 1;8(6):595-605.
doi: 10.1001/jamacardio.2023.1042.

Vigorous Exercise in Patients With Hypertrophic Cardiomyopathy

Rachel Lampert  1 , Michael J Ackerman  2   3   4 , Bradley S Marino  5   6 , Matthew Burg  1 , Barbara Ainsworth  7 , Lisa Salberg  8 , Maria Teresa Tome Esteban  9 , Carolyn Y Ho  10 , Roselle Abraham  11 , Seshadri Balaji  12 , Cheryl Barth  1 , Charles I Berul  13   14 , Martijn Bos  2   3   4 , David Cannom  15 , Lubna Choudhury  16 , Maryann Concannon  17 , Robert Cooper  18 , Richard J Czosek  19 , Anne M Dubin  20 , James Dziura  21 , Benjamin Eidem  22   23 , Michael S Emery  24   25 , N A Mark Estes  26   27 , Susan P Etheridge  28 , Jeffrey B Geske  2 , Belinda Gray  29 , Kevin Hall  30 , Kimberly G Harmon  31 , Cynthia A James  11 , Ashwin K Lal  28 , Ian H Law  32 , Fangyong Li  21 , Mark S Link  26   33 , William J McKenna  34 , Silvana Molossi  35 , Brian Olshansky  36 , Steven R Ommen  2 , Elizabeth V Saarel  5   37 , Sara Saberi  17 , Laura Simone  21 , Gordon Tomaselli  11   38 , James S Ware  39 , Douglas P Zipes  25 , Sharlene M Day  17   40 ; LIVE Consortium
Collaborators, Affiliations
Multicenter Study

Vigorous Exercise in Patients With Hypertrophic Cardiomyopathy

Rachel Lampert et al. JAMA Cardiol. .

Abstract

Importance: Whether vigorous intensity exercise is associated with an increase in risk of ventricular arrhythmias in individuals with hypertrophic cardiomyopathy (HCM) is unknown.

Objective: To determine whether engagement in vigorous exercise is associated with increased risk for ventricular arrhythmias and/or mortality in individuals with HCM. The a priori hypothesis was that participants engaging in vigorous activity were not more likely to have an arrhythmic event or die than those who reported nonvigorous activity.

Design, setting, and participants: This was an investigator-initiated, prospective cohort study. Participants were enrolled from May 18, 2015, to April 25, 2019, with completion in February 28, 2022. Participants were categorized according to self-reported levels of physical activity: sedentary, moderate, or vigorous-intensity exercise. This was a multicenter, observational registry with recruitment at 42 high-volume HCM centers in the US and internationally; patients could also self-enroll through the central site. Individuals aged 8 to 60 years diagnosed with HCM or genotype positive without left ventricular hypertrophy (phenotype negative) without conditions precluding exercise were enrolled.

Exposures: Amount and intensity of physical activity.

Main outcomes and measures: The primary prespecified composite end point included death, resuscitated sudden cardiac arrest, arrhythmic syncope, and appropriate shock from an implantable cardioverter defibrillator. All outcome events were adjudicated by an events committee blinded to the patient's exercise category.

Results: Among the 1660 total participants (mean [SD] age, 39 [15] years; 996 male [60%]), 252 (15%) were classified as sedentary, and 709 (43%) participated in moderate exercise. Among the 699 individuals (42%) who participated in vigorous-intensity exercise, 259 (37%) participated competitively. A total of 77 individuals (4.6%) reached the composite end point. These individuals included 44 (4.6%) of those classified as nonvigorous and 33 (4.7%) of those classified as vigorous, with corresponding rates of 15.3 and 15.9 per 1000 person-years, respectively. In multivariate Cox regression analysis of the primary composite end point, individuals engaging in vigorous exercise did not experience a higher rate of events compared with the nonvigorous group with an adjusted hazard ratio of 1.01. The upper 95% 1-sided confidence level was 1.48, which was below the prespecified boundary of 1.5 for noninferiority.

Conclusions and relevance: Results of this cohort study suggest that among individuals with HCM or those who are genotype positive/phenotype negative and are treated in experienced centers, those exercising vigorously did not experience a higher rate of death or life-threatening arrhythmias than those exercising moderately or those who were sedentary. These data may inform discussion between the patient and their expert clinician around exercise participation.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Lampert reported receiving grants from the National Institutes of Health; speaker honoraria, advisory board fees, and research funding from Medtronic; speaker honoraria and research funding from Abbott/St Jude; and research funding from Boston Scientific outside the submitted work. Dr Ackerman reported receiving consultant fees from Abbott, Bristol Myers Squibb, Daichi Sankyo, Invitae, Medtronic, and Tenaya Therepeutics and equity/royalties from AliveCor, Anuman, AMRGO Pharma, Pfizer, and Thryv Therapetics. Dr Marino reported receiving grants from Ann & Robert H. Lurie Children’s Hospital of Chicago during the conduct of the study. Dr Burg reported receiving grants from the National Institutes of Health during the conduct of the study. Dr Esteban reported receiving consultant fees from Bristol Myers Squibb and Cytokenetics outside the submitted work. Dr Ho reported receiving grants from the National Institutes of Health, Bristol Myers Squibb, Pfizer, Biomarin, and Cytokinetics and personal fees from MyoKardia, Bristol Myers Squibb, Tenaya, Biomarin, Lexicon, viz.AI, and Cytokinetics outside the submitted work. Dr Balaji reported receiving grants from Medtronic and personal fees from Milestone Pharmaceuticals outside the submitted work. Dr Choudhury reported receiving grants from the National Heart, Lung, and Blood Institute during the conduct of the study. Dr Czosek reported receiving grants from the National Institutes of Health during the conduct of the study. Dr Dziura reported receiving grants from the National Heart, Lung, and Blood Institute and the National Institutes of Health, a part of the US Department of Health and Human Services, during the conduct of the study. Dr Emery reported receiving grants from Yale University and advisory board/speakers’ bureau fees from Bristol Meyers Squibb outside the submitted work. Dr Gray reported receiving advisory board fees from Bristol Myers Squibb outside the submitted work. Dr James reported receiving grants from Lexeo, Eicosis, and StrideBio and personal fees from Lexeo and Pfizer outside the submitted work. Dr Lal reported receiving writing assistance from Pfizer for a Duchenne muscular dystrophy project and grants from Novartis and Pfizer outside the submitted work. Dr Law reported receiving consultant fees from Medtronic and St Jude and speaker fees from Boston Scientific outside the submitted work. Dr Molossi reported receiving grants from the National Institutes of Health and the National Heart, Lung, and Blood Institute during the conduct of the study. Dr Olshansky reported being a data safety monitoring board member for AstraZeneca outside the submitted work. Dr Saberi reported receiving personal fees from Bristol Myers Squibb and Cytokinetics and being an executive committee member for the Hypertrophic Cardiomyopathy Medical Society. Dr Simone reported receiving grants from the National Institutes of Health during the conduct of the study. Dr Tomaselli reported receiving grants from the National Institutes of Health and personal fees from Leducq Foundation outside the submitted work. Dr Ware reported receiving grants from the Medical Research Council (UK), British Heart Foundation, the NIHR Imperial College Biomedical Research Centre, and the Royston Centre for Cardiomyopathy; and research/consultant fees from MyoKardia/Bristol Myers Squibb, Pfizer, and Foresite Labs outside the submitted work. Dr Day reported receiving grants from the National Institutes of Health, Lexicon Pharmaceuticals, and Bristol Myers Squibb and personal fees from Lexicon Pharmaceuticals and Cytokinetics outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Kaplan-Meier Survival Curve for Freedom From Composite End Point (Death, Cardiac Arrest, Appropriate Implantable Cardioverter Defibrillator Shock, or Arrhythmic Syncope) by Exercise Group
Vigorous and nonvigorous groups did not differ in freedom from composite end point.
Figure 2.
Figure 2.. Forest Plot for Hazard Ratio (HR) (1-Sided 95% CI) Comparing Composite Outcomes Between Exercise Groups
HRs for primary, secondary, and post hoc analyses comparing the composite outcome (death, cardiac arrest, appropriate implantable cardioverter defibrillator [ICD] shock, arrhythmic syncope) between those exercising vigorously and those exercising nonvigorously. Presented are 90% 2-sided CIs. The upper limits of these intervals correspond to a 1-sided .05 significance level used to evaluate noninferiority. Primary analysis is shown followed by 2 secondary analyses: pairwise comparisons of the 3 groups and after excluding noncompetitive vigorous individuals to compare vigorous-competitive vs nonvigorous. Post hoc analyses are shown of subgroups. aThe first subgroup included those with overt hypertrophic cardiomyopathy (HCM), ie, phenotype-positive only, and controlled for prespecified covariates age, sex, race, recruitment method (site or self), age at diagnosis, and presence of an ICD. bThe next model added sudden cardiac death risk factors that differed by an effect size of at least 12% between the groups (history of sudden cardiac arrest and septal thickness). cThe final subgroup excluded those with exercise-related symptoms (ie, asymptomatic, phenotype-positive only).
See this image and copyright information in PMC

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