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NCT Number: NCT04153162

Non-Invasive Radiation Ablation in Patients With Hypertrophic CardioMyopathy: NIRA-HOCM

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:

1. open heart surgery (myectomy) where a surgeon cuts out the thick muscle 2. 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.

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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barts Heart Centre

London, EC1A 7BE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Stereotactic body radiation therapy

Device

Stereotactic body radiation therapy delivered to reduce LVOTO in patients with HCM

Primary outcomes

  1. 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.

Secondary outcomes

  1. Assessment of MACE endpoints

    Time frame: 3, 6 and 12 months

    MACE = death, heart failure, myocardial infarction and stroke

  2. Change in aortic valve and mitral valve function

    Time frame: 3, 6 and 12 months

    Echocardiography assessed aortic and mitral valve function

  3. Left anterior descending artery patency

    Time frame: 12 months

    Patency of left anterior descending artery with cardiac CT

  4. Presence of radiation pneumonitis

    Time frame: 12 months

    Presence of radiation pneumonitis on CT

  5. Development of complete heart block, atrial or ventricular arrhythmias

    Time frame: 3, 6 and 12 months

    Cardiac device (ICD or pacemaker) check

  6. Change in LVOT gradient

    Time frame: 3, 6 and 12 months

    Assessed with transthoracic echocardiography using same loading conditions as baseline

  7. Change in functional class

    Time frame: 6 and 12 months

    Change in NYHA and CCS class from baseline

  8. Change in frequency of syncope and pre-syncope

    Time frame: 6 and 12 months

    Baseline to 6 and 12 months

  9. Change in exercise capacity

    Time frame: 6 and 12 months compared to Baseline

    6 minute Walk Test

  10. Change in health status

    Time frame: 6 and 12 months compared to Baseline

    EQ-5D-5L

  11. Troponin T elevation

    Time frame: 1,2,3 days post ablation

    Measurement of Trop T

  12. Change in LV wall thickness

    Time frame: 6 months

    CMR assessed thickness

  13. Left ventricular ejection fraction (LVEF)

    Time frame: 3, 6 and 12 months

    Measured on echocardiography

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Collaborators

  • Barts Cardiovascular CTU (Queen Mary University of London)
  • Barts Clinical Trial Unit

Registry information

Official study title

Non-Invasive Radiation Ablation for Septal Reduction in Patients With Hypertrophic Obstructive CardioMyopathy: First in Man Pilot Study

Acronym: NIRA-HOCM

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 6, 2019
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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