Exercise Training in Hypertrophic Cardiomyopathy: (SAFE-HCM)

NCT05459467 | Completed DMC

• 1 other identifier: 17.0215
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypertrophic Cardiomyopathy

Keywords

Hypertrophic cardiomyopathy; Cardiac rehabilitation; Exercise; High intensity

Outcome Measures

Primary Outcomes (2)

• Safety composite outcome

  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.

  6 months

• Feasibility (qualitative outcome)

  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

  12 weeks

Secondary Outcomes (20)

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

  6 months

• Impact on exercise capacity; total exercise time (tMax) (seconds)

  6 months

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

  6 months

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

  6 months

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

  6 months

Study Arms (2)

Exercise

EXPERIMENTAL

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?.

Other: Exercise

Usual care

NO INTERVENTION

Patients exercised as per usual.

Interventions

Exercise OTHER

12 weeks high intensity exercise programme

Exercise

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St George's, University of London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• King's College Hospital NHS Trust: collaborator

Study Sites (3)

Guys and St Thomas's Hospital

London, SE1 9RT, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

St George's Hospital

London, SW17 0QT, United Kingdom

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael Papadakis

  St George's University London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Masking for randomisation and analysis
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: July 15, 2022
• Study Start: January 1, 2018
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)