Hypertrophic CardiomyopathySAFE-HCMNCT05459467
Exercise Training in Hypertrophic Cardiomyopathy: (SAFE-HCM)
A study testing Exercise in people with Hypertrophic Cardiomyopathy, run by St George's, University of London at 3 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Jan 2018to 3 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- Patients able to exercise
- Patients able to commit to the full duration of the exercise programme
- Patients able to lie flat
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Guys and St Thomas's Hospital
London, SE1 9RT
Kings College Hospital
London, SE5 9RS
St George's Hospital
London, SW17 0QT
About this study
Official title: Safety and Outcomes of a Structured Exercise Programme in Young Patients With Hypertrophic Cardiomyopathy: the SAFE HCM Trial
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.
Read the 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
- Being tested
- Exercise
- Keywords
- Hypertrophic cardiomyopathy, Cardiac rehabilitation, Exercise, High intensity
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
12 weeks high intensity exercise programme
| Study group | Role | What they receive |
|---|---|---|
| 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?. Receives: Other: Exercise |
| Usual care | No intervention | Patients exercised as per usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 weeks
Secondary outcomes (20)
Impact on exercise capacity; time to anaerobic threshold (tAT) (seconds)
This variable will be assessed individually and compared to baseline values post testing and at 6 months.
Measured: 6 months
Impact on exercise capacity; total exercise time (tMax) (seconds)
This variable will be assessed individually and compared to baseline values post testing and at 6 months.
Measured: 6 months
Impact on exercise capacity; VO2(ml/kg/min) at AT (VO2/kgAT) (ml/kg/min)
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.
Measured: 6 months
Impact on exercise capacity; peak VO2(ml/kg/min) (VO2/kgMax) (ml/kg/min)
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.
Measured: 6 months
Impact on exercise capacity; VE/VCO2 slope (ratio)
This variable will be assessed individually and compared to baseline values post testing and at 6 months.
Measured: 6 months
Impact on exercise capacity; physical activity levels (hours/week)
This variable will be assessed individually and compared to baseline values post testing and at 6 months.
Measured: 6 months
Impact on cardiovascular risk factors; blood pressure (BP) (mmHg)
This variable will be assessed individually and compared to baseline values post testing and at 6 months.
Measured: 6 months
Impact on cardiovascular risk factors; body mass index (BMI) (kg/m2)
This variable will be assessed individually and compared to baseline post testing and at 6 months.
Measured: 6 months
Impact on cardiovascular risk factors; lipid profile (mmol/l)
This variable will be assessed individually and compared to baseline values post testing.
Measured: 12 weeks
Impact on cardiovascular risk factors; HbA1c (mmol/mol)
This variable will be assessed individually and compared to baseline values post testing.
Measured: 12 weeks
Impact on QoL and psychological parameters; Short form 36 (SF36) scores
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.
Measured: 6 months
Impact on QoL and psychological parameters; Hospital anxiety and depression scale (HADS) scores
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.
Measured: 6 months
Impact on QoL and psychological parameters; WHO disability assessment scale II (WHODAS II) scores
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.
Measured: 6 months
Impact on disease phenotype-cardiac biomarkers; troponin (ng/l)
This variable will be assessed individually and compared to baseline values post testing.
Measured: 12 weeks
Impact on disease phenotype-cardiac biomarkers; BNP (ng/l)
This variable will be assessed individually and compared to baseline values post testing.
Measured: 12 weeks
Impact on disease phenotype-echocardiographic outcomes; LA volume (ml)
This variable will be assessed individually and compared to baseline values post testing.
Measured: 12 weeks
Impact on disease phenotype-echocardiographic outcomes; LVEDD (mm)
This variable will be assessed individually and compared to baseline values post testing.
Measured: 12 weeks
Impact on disease phenotype-echocardiographic outcomes; LVWT (mm)
This variable will be assessed individually and compared to baseline values post testing.
Measured: 12 weeks
Impact on disease phenotype-echocardiographic outcomes; diastolic parameters (E/E', E/A))
This variable will be assessed individually and compared to baseline values post testing.
Measured: 12 weeks
Impact on disease phenotype-ventricular ectopic burden;
The absolute number of ventricular ectopics will be assessed and compared to baseline values post testing post testing and at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Jan 2018
- Primary completion3 Mar 2020
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Michael Papadakis, Principal investigator, St George's University London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459467
- Sponsor's protocol ID
- 17.0215
- Acronym
- SAFE-HCM
- Status last verified
- Jul 2022
- First submitted
- 27 Feb 2020
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Outcomes of a Structured Exercise Programme in Young Patients With Hypertrophic Cardiomyopathy: the SAFE HCM Trial
- ClinicalTrials.gov ID
- NCT05459467
- Acronym / sponsor ID
- SAFE-HCM / 17.0215
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Hypertrophic cardiomyopathy, Cardiac rehabilitation, Exercise, High intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Trust
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseParticipants 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?. |
| Usual care | No intervention | –Patients exercised as per usual. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise12 weeks high intensity exercise programme | Other | Exercise |
Primary outcome
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.
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
20 secondary outcomes
Impact on exercise capacity; time to anaerobic threshold (tAT) (seconds)
Time frame: 6 months
Impact on exercise capacity; total exercise time (tMax) (seconds)
Time frame: 6 months
Impact on exercise capacity; VO2(ml/kg/min) at AT (VO2/kgAT) (ml/kg/min)
Time frame: 6 months
Impact on exercise capacity; peak VO2(ml/kg/min) (VO2/kgMax) (ml/kg/min)
Time frame: 6 months
Impact on exercise capacity; VE/VCO2 slope (ratio)
Time frame: 6 months
Impact on exercise capacity; physical activity levels (hours/week)
Time frame: 6 months
Impact on cardiovascular risk factors; blood pressure (BP) (mmHg)
Time frame: 6 months
Impact on cardiovascular risk factors; body mass index (BMI) (kg/m2)
Time frame: 6 months
Impact on cardiovascular risk factors; lipid profile (mmol/l)
Time frame: 12 weeks
Impact on cardiovascular risk factors; HbA1c (mmol/mol)
Time frame: 12 weeks
Impact on QoL and psychological parameters; Short form 36 (SF36) scores
Time frame: 6 months
Impact on QoL and psychological parameters; Hospital anxiety and depression scale (HADS) scores
Time frame: 6 months
Impact on QoL and psychological parameters; WHO disability assessment scale II (WHODAS II) scores
Time frame: 6 months
Impact on disease phenotype-cardiac biomarkers; troponin (ng/l)
Time frame: 12 weeks
Impact on disease phenotype-cardiac biomarkers; BNP (ng/l)
Time frame: 12 weeks
Impact on disease phenotype-echocardiographic outcomes; LA volume (ml)
Time frame: 12 weeks
Impact on disease phenotype-echocardiographic outcomes; LVEDD (mm)
Time frame: 12 weeks
Impact on disease phenotype-echocardiographic outcomes; LVWT (mm)
Time frame: 12 weeks
Impact on disease phenotype-echocardiographic outcomes; diastolic parameters (E/E', E/A))
Time frame: 12 weeks
Impact on disease phenotype-ventricular ectopic burden;
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Individual participant dataSharing planned: No. Currently individual participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Papadakis principal investigator
St George's University London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Hypertrophic Cardiomyopathy, run by St George's, University of London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety composite outcome (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.