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Search / Trial NCT05459467

Exercise Training in Hypertrophic Cardiomyopathy: (SAFE-HCM)

Launched by ST GEORGE'S, UNIVERSITY OF LONDON · Jul 12, 2022

Trial Information

Current as of May 14, 2025

Completed

Keywords

Hypertrophic Cardiomyopathy Cardiac Rehabilitation Exercise High Intensity

ClinConnect Summary

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 burde...

Gender

ALL

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

About St George's, University Of London

St George's, University of London is a leading academic institution dedicated to advancing healthcare through innovative research and education. As a prominent clinical trial sponsor, the university leverages its expertise in biomedical sciences, medicine, and health professions to conduct rigorous clinical studies aimed at improving patient outcomes. With a commitment to ethical practices and collaboration across disciplines, St George's fosters an environment that encourages groundbreaking discoveries and the translation of research findings into clinical applications, ultimately enhancing the quality of care in diverse medical fields.

Locations

London, , United Kingdom

London, , United Kingdom

London, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Michael Papadakis

Principal Investigator

St George's University London

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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