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NCT Number: NCT05459467

Exercise Training in Hypertrophic Cardiomyopathy: (SAFE-HCM)

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.

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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Behavior Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases Motor Activity

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guys and St Thomas's Hospital, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

12 weeks high intensity exercise programme

Primary outcomes

  1. Safety composite outcome

    Time frame: 6 months

    This will be reported as the number of people who reach the composite safety outcome (the occurrence of at least one) of the following measured variables 1)cardiovascular death; 2)cardiac arrest; 3) appropriate or inappropriate ICD therapy; 4)exercise induced syncope; 5)sustained ventricular tachycardia; 6) non-sustained ventricular tachycardia; or 7)sustained atrial arrhythmias >30seconds post testing and at 6 months.

  2. Feasibility (qualitative outcome)

    Time frame: 12 weeks

    Feasibility will be reported qualitatively using an open ended questionnaire through analysis of the following a) response to invitation to participate and reasons for refusal; b) adherence to the cardiac rehabilitation programme; c) practical issues related to the programme including staffing and resource assessment; d) acceptability of the intervention and educational materials provided to patients and families

Secondary outcomes

  1. Impact on exercise capacity; time to anaerobic threshold (tAT) (seconds)

    Time frame: 6 months

    This variable will be assessed individually and compared to baseline values post testing and at 6 months.

  2. Impact on exercise capacity; total exercise time (tMax) (seconds)

    Time frame: 6 months

    This variable will be assessed individually and compared to baseline values post testing and at 6 months.

  3. Impact on exercise capacity; VO2(ml/kg/min) at AT (VO2/kgAT) (ml/kg/min)

    Time frame: 6 months

    The anaerobic threshold (AT) was calculated initially using the V slope method (visual estimation from the VCO2 and VO2 graphs at the point where the slope of the VCO2 curve exceeded the slope of the VO2 curve). This was checked manually using the raw data and 10 second averaging. All data was additionally averaged over 10 seconds at this point and the averaged VO2 ml/kg/min value used as the VO2 at the AT. This variable will be assessed individually and compared to baseline values post testing and at 6 months.

  4. Impact on exercise capacity; peak VO2(ml/kg/min) (VO2/kgMax) (ml/kg/min)

    Time frame: 6 months

    CPET analysis was performed using COSMED Quark CPET metabolic cart (Rome, Italy). This automatically calculated peak VO2 ml/min and converted it to ml/kg/min using the patient's weight which had been inputted into the program prior to commencing the CPET. This variable will be assessed individually and compared to baseline values post testing and at 6 months.

  5. Impact on exercise capacity; VE/VCO2 slope (ratio)

    Time frame: 6 months

    This variable will be assessed individually and compared to baseline values post testing and at 6 months.

  6. Impact on exercise capacity; physical activity levels (hours/week)

    Time frame: 6 months

    This variable will be assessed individually and compared to baseline values post testing and at 6 months.

  7. Impact on cardiovascular risk factors; blood pressure (BP) (mmHg)

    Time frame: 6 months

    This variable will be assessed individually and compared to baseline values post testing and at 6 months.

  8. Impact on cardiovascular risk factors; body mass index (BMI) (kg/m2)

    Time frame: 6 months

    This variable will be assessed individually and compared to baseline post testing and at 6 months.

  9. Impact on cardiovascular risk factors; lipid profile (mmol/l)

    Time frame: 12 weeks

    This variable will be assessed individually and compared to baseline values post testing.

  10. Impact on cardiovascular risk factors; HbA1c (mmol/mol)

    Time frame: 12 weeks

    This variable will be assessed individually and compared to baseline values post testing.

  11. Impact on QoL and psychological parameters; Short form 36 (SF36) scores

    Time frame: 6 months

    This variable will be assessed individually and compared to baseline values post testing and at 6 months. The SF-36 is comprised of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is converted into a 0-100 scale, with a lower score denoting greater disability.

  12. Impact on QoL and psychological parameters; Hospital anxiety and depression scale (HADS) scores

    Time frame: 6 months

    This variable will be assessed individually and compared to baseline values post testing and at 6 months. The HADS questionnaire consists of seven items each for depression and anxiety. Each item is scored from zero to three, with three the highest anxiety or depression level. Either an anxiety or depression score of >8 points (total 21) denotes considerable symptoms of anxiety or depression.

  13. Impact on QoL and psychological parameters; WHO disability assessment scale II (WHODAS II) scores

    Time frame: 6 months

    This variable will be assessed individually and compared to baseline values post testing and at 6 months. The WHODAS II score can be calculated using simple scoring where the following scores are assigned to each item - none (1), mild (2) moderate (3), severe (4) and extreme (5). The scores are then summed, with a higher score denoting greater disability.

  14. Impact on disease phenotype-cardiac biomarkers; troponin (ng/l)

    Time frame: 12 weeks

    This variable will be assessed individually and compared to baseline values post testing.

  15. Impact on disease phenotype-cardiac biomarkers; BNP (ng/l)

    Time frame: 12 weeks

    This variable will be assessed individually and compared to baseline values post testing.

  16. Impact on disease phenotype-echocardiographic outcomes; LA volume (ml)

    Time frame: 12 weeks

    This variable will be assessed individually and compared to baseline values post testing.

  17. Impact on disease phenotype-echocardiographic outcomes; LVEDD (mm)

    Time frame: 12 weeks

    This variable will be assessed individually and compared to baseline values post testing.

  18. Impact on disease phenotype-echocardiographic outcomes; LVWT (mm)

    Time frame: 12 weeks

    This variable will be assessed individually and compared to baseline values post testing.

  19. Impact on disease phenotype-echocardiographic outcomes; diastolic parameters (E/E', E/A))

    Time frame: 12 weeks

    This variable will be assessed individually and compared to baseline values post testing.

  20. Impact on disease phenotype-ventricular ectopic burden;

    Time frame: 6 months

    The absolute number of ventricular ectopics will be assessed and compared to baseline values post testing post testing and at 6 months.

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Collaborators

  • Guy's and St Thomas' NHS Foundation Trust
  • King's College Hospital NHS Trust

Registry information

Official study title

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

Acronym: SAFE-HCM

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 15, 2022
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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