Exercise Training in Hypertrophic Cardiomyopathy: (SAFE-HCM)

NCT ID: NCT05459467

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-03-03

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Exercise

Participants began exercising at 70% of their heart rate reserve (HRR). The Borg scale was used to monitor exertion during the programme. Participants were provided with watches to monitor their HR and also wore ECG monitors to assess for arrhythmias during exercise classes.

Sessions consisted of a circuit of set exercises alternating between aerobic/cardiovascular and resistance exercises. Participants were progressed in a graded fashion (up to a maximum of 85% HRR). Participants were also expected to participate in a predefined exercise session remotely.

Educational session took place in the half an hour following the exercise session. Examples of topics covered included: living with HCM, medications, diet, stress/anxiety management and mindfulness, ICD therapy- what to expect?.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

12 weeks high intensity exercise programme

Usual care

Patients exercised as per usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

12 weeks high intensity exercise programme

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• HCM*
• Age range (16-60 years)
• All genders
• All ethnicities
• Symptomatic and/or asymptomatic HCM patients (NYHA functional class I-II) stable on medication over the preceding 3 months
• Patients may have ICDs
• Patients able to exercise
• Patients able to commit to the full duration of the exercise programme
• Patients able to lie flat

Exclusion Criteria

• Competitive athletes (individuals who participate in team or individual sports that require systematic training to participate in regular competition against others)
• Exercise induced syncope
• Uncontrolled ventricular arrhythmias (arrhythmias which cause distracting/disabling symptoms or have caused or may cause incapacity)
• NYHA class III-IV
• Severe LV failure (ejection fraction <35%)
• Exercise limited by a non-cardiac (unrelated to HCM) cause
• Surgical myectomy
• Awaiting or recent device implantation (within the last 3 months if due to an arrhythmic events, 4 weeks for primary prevention)
• Known coronary artery disease - defined as a coronary artery lesion of >50% on coronary angiography or known coronary intervention
• Renal failure (eGFR <30ml/min, chronic kidney disease stage 4 and 5 or acute renal failure)
• Patients with Friedrich's ataxia, Noonan syndrome, Anderson-Fabry disease and other disorders associated with cardiac hypertrophy
• Pregnancy

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role: collaborator

St George's, University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Papadakis

Role: PRINCIPAL_INVESTIGATOR

St George's University London

Locations

Guys and St Thomas's Hospital

London, , United Kingdom

Kings College Hospital

London, , United Kingdom

St George's Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

17.0215

Identifier Type: -

Identifier Source: org_study_id