NCT05459467

Exercise Training in Hypertrophic Cardiomyopathy: (SAFE-HCM)

Safety and Outcomes of a Structured Exercise Programme in Young Patients With Hypertrophic Cardiomyopathy: the SAFE HCM Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: St George's, University of London · Academic / Other
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To explore the feasibility, safety, health and psychological benefits of a 12-week high intensity exercise programme in a young group of individuals with hypertrophic cardiomyopathy (HCM). This will pave the way for a large-scale randomised study of safety of exercise in HCM, the results of which will strengthen the evidence base for exercise recommendations.

Detailed description

A greater understanding of the pathogenic mechanisms underpinning HCM has translated to improved medical care and better survival of affected individuals. Historically these patients were considered to be at high risk of sudden cardiac death during exercise, therefore exercise recommendations were highly conservative and promoted a sedentary life style. There is emerging evidence which suggests that exercise in HCM has a favourable effect on cardiovascular remodelling and moderate exercise programmes have not raised any safety concerns. Furthermore, individuals with HCM have a similar burden of atherosclerotic risk factors as the general population in whom exercise has been associated with a reduction in myocardial infarction, stroke and heart failure, especially among those with a high-risk burden. Small studies have revealed that athletes who choose to continue with regular competition do not demonstrate adverse outcomes when compared to those who discontinue sport, and active individuals implanted with an implantable cardioverter defibrillator (ICD) do not have an increased risk of appropriate shocks or other adverse events. The recently published exercise recommendations from the European Society of Cardiology account for more contemporary evidence and adopt a more liberal stance regarding competitive and high intensity sport in individuals with low-risk HCM. However, further work is required into exercise prescription in younger non competitive individuals participating in higher intensity exercise. Moreover low/moderate intensity exercise may be appropriate for older HCM patients, it is unlikely to attract younger, often asymptomatic patients, who wish to engage in higher intensity regimes.Therefore this study aims to assess the feasibility, safety and outcomes of an individually tailored, high intensity exercise programme in young patients with HCM.

Conditions

• Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
OTHER	Exercise	12 weeks high intensity exercise programme

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-03-03
• Completion: 2020-03-03
• First posted: 2022-07-15
• Last updated: 2022-07-15

Locations

3 sites across 1 country: United Kingdom