Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT05459467
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
60 Years
Study:
NCT05459467
Study Brief:
Protocol Section:
NCT05459467