Hypertrophic CardiomyopathyNIRA-HOCMNCT04153162
Non-Invasive Radiation Ablation in Patients With Hypertrophic CardioMyopathy: NIRA-HOCM
A study testing Stereotactic body radiation therapy in people with Hypertrophic Cardiomyopathy, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Hypertrophic cardiomyopathy (HCM) is a common disease of the heart which causes thickening of the heart muscle. HCM primarily affects the muscle of the main pumping chamber of the heart (the left ventricle) and particularly the septum (this is the muscular wall which separates the right and left side of the heart). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Stereotactic body radiation therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jan 2020to 21 Jan 2025
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Limiting, drug refractory symptoms secondary to left ventricular outflow tract obstruction
- Previously failed invasive septal reduction therapy (ethanol septal ablation/surgical myectomy) or inability to perform invasive septal reduction due to increased risk/co-morbidities/anatomical considerations following specialist MDT review
- A device (permanent pacemaker or implantable cardioverter defibrillator) in situ.
- Ventricular septal thickness at site ablation ≥ 16mm.
- Patient able to tolerate lying flat for one hour
- High target-surrogacy of ICD/pacing lead for cardiac motion (from cardiac-gated MRI or cardiac-gated CT with the patient in pacing mode used for treatment)
- Successful completion of ICD lead tip tracking test ("patient dummy run") with the patient in pacing mode used for treatment
- Adult Patients aged 18 and over willing and able to give written informed consent
Who cannot join
- New York Heart Association I-II
- Canadian Cardiovascular Society class 1-2
- Follow-up impossible (e.g. no fixed abode)
- Weight of patient that exceeds the maximum limit of CMR table (170kg)
- Subjects of childbearing potential unless βHCG negative and on contraception
- Lack of cardiac device with anti-bradycardia pacing capabilities
- Previous chest radiotherapy
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Invasive Radiation Ablation for Septal Reduction in Patients With Hypertrophic Obstructive CardioMyopathy: First in Man Pilot Study
Hypertrophic cardiomyopathy (HCM) is a common disease of the heart which causes thickening of the heart muscle.
HCM primarily affects the muscle of the main pumping chamber of the heart (the left ventricle) and particularly the septum (this is the muscular wall which separates the right and left side of the heart). In a subgroup of patients, the thickened heart muscle at the septum prevents blood from leaving the heart during contraction (this is called obstruction). This form of the disease is called hypertrophic obstructive cardiomyopathy (HOCM).
Read more
HOCM is a common cause of shortness of breath, chest pain and dizzy spells. These symptoms are treated with tablets and if symptoms are uncontrolled, patients are often offered invasive treatment to get rid of some of the thick heart muscle and reduce obstruction. This is achieved either by:
- open heart surgery (myectomy) where a surgeon cuts out the thick muscle
- injection of alcohol to the thick heart muscle via a tube in the wrist or groin (alcohol septal ablation). The alcohol thins the heart muscle at the point of obstruction, mimicking the effects of myectomy.
Unfortunately, some patients are not suitable for both these procedures.
This study will test whether radiotherapy, usually used for the treatment of tumours, can be used to destroy the thick heart muscle at the point of obstruction safely and effectively. Study patients will be monitored following the procedure and the investigators plan to measure the levels of heart muscle thinning, reduction of obstruction and improvement in symptoms and importantly document any side effects.
Radiotherapy works by precisely targeting high energy X-rays (ionising radiation) at a specific area of the body with the aim of destroying abnormal tissue. CyberKnife is one of the latest radiotherapy delivery systems, which will deliver highly focussed and accurate radiotherapy.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Stereotactic body radiation therapy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiation therapyDevice
Stereotactic body radiation therapy delivered to reduce LVOTO in patients with HCM
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic body radiation therapy | Experimental | In patients with HCM and refractory symptoms from LVOTO, stereotactic body radiation therapy will be delivered locally to relieve symptoms Receives: Device: Stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate acute (≤ 90 days) safety of non-invasive SBRT.
The primary safety endpoint is defined as serious adverse events (SAEs) that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive alcohol septal-ablation procedures.
Measured: 90 days
Secondary outcomes (13)
Assessment of MACE endpoints
MACE = death, heart failure, myocardial infarction and stroke
Measured: 3, 6 and 12 months
Change in aortic valve and mitral valve function
Echocardiography assessed aortic and mitral valve function
Measured: 3, 6 and 12 months
Left anterior descending artery patency
Patency of left anterior descending artery with cardiac CT
Measured: 12 months
Presence of radiation pneumonitis
Presence of radiation pneumonitis on CT
Measured: 12 months
Development of complete heart block, atrial or ventricular arrhythmias
Cardiac device (ICD or pacemaker) check
Measured: 3, 6 and 12 months
Change in LVOT gradient
Assessed with transthoracic echocardiography using same loading conditions as baseline
Measured: 3, 6 and 12 months
Change in functional class
Change in NYHA and CCS class from baseline
Measured: 6 and 12 months
Change in frequency of syncope and pre-syncope
Baseline to 6 and 12 months
Measured: 6 and 12 months
Change in exercise capacity
6 minute Walk Test
Measured: 6 and 12 months compared to Baseline
Change in health status
EQ-5D-5L
Measured: 6 and 12 months compared to Baseline
Troponin T elevation
Measurement of Trop T
Measured: 1,2,3 days post ablation
Change in LV wall thickness
CMR assessed thickness
Measured: 6 months
Left ventricular ejection fraction (LVEF)
Measured on echocardiography
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start7 Jan 2020
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Barts Cardiovascular CTU (Queen Mary University of London), Barts Clinical Trial Unit
- Responsible party
- Sponsor
- Investigators
- Costas O'Mahony, FRCP, MD, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153162
- Sponsor's protocol ID
- NIRA-HOCM 1.1
- Acronym
- NIRA-HOCM
- Status last verified
- Mar 2025
- First submitted
- 4 Nov 2019
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Radiation Ablation for Septal Reduction in Patients With Hypertrophic Obstructive CardioMyopathy: First in Man Pilot Study
- ClinicalTrials.gov ID
- NCT04153162
- Acronym / sponsor ID
- NIRA-HOCM / NIRA-HOCM 1.1
- Conditions
- Hypertrophic Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Barts Cardiovascular CTU (Queen Mary University of London), Barts Clinical Trial Unit
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 6 Nov 2019 (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.
Hypertrophic cardiomyopathy (HCM) is a common disease of the heart which causes thickening of the heart muscle.
HCM primarily affects the muscle of the main pumping chamber of the heart (the left ventricle) and particularly the septum (this is the muscular wall which separates the right and left side of the heart). In a subgroup of patients, the thickened heart muscle at the septum prevents blood from leaving the heart during contraction (this is called obstruction). This form of the disease is called hypertrophic obstructive cardiomyopathy (HOCM).
HOCM is a common cause of shortness of breath, chest pain and dizzy spells. These symptoms are treated with tablets and if symptoms are uncontrolled, patients are often offered invasive treatment to get rid of some of the thick heart muscle and reduce obstruction. This is achieved either by:
- open heart surgery (myectomy) where a surgeon cuts out the thick muscle
- injection of alcohol to the thick heart muscle via a tube in the wrist or groin (alcohol septal ablation). The alcohol thins the heart muscle at the point of obstruction, mimicking the effects of myectomy.
Unfortunately, some patients are not suitable for both these procedures.
This study will test whether radiotherapy, usually used for the treatment of tumours, can be used to destroy the thick heart muscle at the point of obstruction safely and effectively. Study patients will be monitored following the procedure and the investigators plan to measure the levels of heart muscle thinning, reduction of obstruction and improvement in symptoms and importantly document any side effects.
Radiotherapy works by precisely targeting high energy X-rays (ionising radiation) at a specific area of the body with the aim of destroying abnormal tissue. CyberKnife is one of the latest radiotherapy delivery systems, which will deliver highly focussed and accurate radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic body radiation therapy | Experimental | Device: Stereotactic body radiation therapyIn patients with HCM and refractory symptoms from LVOTO, stereotactic body radiation therapy will be delivered locally to relieve symptoms |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Limiting, drug refractory symptoms secondary to left ventricular outflow tract obstruction
- Previously failed invasive septal reduction therapy (ethanol septal ablation/surgical myectomy) or inability to perform invasive septal reduction due to increased risk/co-morbidities/anatomical considerations following specialist MDT review
- A device (permanent pacemaker or implantable cardioverter defibrillator) in situ.
- Ventricular septal thickness at site ablation ≥ 16mm.
- Patient able to tolerate lying flat for one hour
Key exclusion criteria (8 listed)
- New York Heart Association I-II
- Canadian Cardiovascular Society class 1-2
- Follow-up impossible (e.g. no fixed abode)
- Weight of patient that exceeds the maximum limit of CMR table (170kg)
- Subjects of childbearing potential unless βHCG negative and on contraception
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 |
|---|---|---|
| Stereotactic body radiation therapyStereotactic body radiation therapy delivered to reduce LVOTO in patients with HCM | Device | Stereotactic body radiation therapy |
Primary outcome
Demonstrate acute (≤ 90 days) safety of non-invasive SBRT.
Time frame: 90 days
The primary safety endpoint is defined as serious adverse events (SAEs) that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive alcohol septal-ablation procedures.
13 secondary outcomes
Assessment of MACE endpoints
Time frame: 3, 6 and 12 months
Change in aortic valve and mitral valve function
Time frame: 3, 6 and 12 months
Left anterior descending artery patency
Time frame: 12 months
Presence of radiation pneumonitis
Time frame: 12 months
Development of complete heart block, atrial or ventricular arrhythmias
Time frame: 3, 6 and 12 months
Change in LVOT gradient
Time frame: 3, 6 and 12 months
Change in functional class
Time frame: 6 and 12 months
Change in frequency of syncope and pre-syncope
Time frame: 6 and 12 months
Change in exercise capacity
Time frame: 6 and 12 months compared to Baseline
Change in health status
Time frame: 6 and 12 months compared to Baseline
Troponin T elevation
Time frame: 1,2,3 days post ablation
Change in LV wall thickness
Time frame: 6 months
Left ventricular ejection fraction (LVEF)
Time frame: 3, 6 and 12 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 17 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Costas O'Mahony, FRCP, MD principal investigator
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic body radiation therapy in people with Hypertrophic Cardiomyopathy, run by Barts & The London NHS Trust at 1 site 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 8 inclusion and 8 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 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Demonstrate acute (≤ 90 days) safety of non-invasive SBRT. (time frame: 90 days). 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 17 Mar 2025.