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

NCT04153162 | Completed DMC

• 1 other identifier: NIRA-HOCM 1.1
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (13)

• Assessment of MACE endpoints

  3, 6 and 12 months

• Change in aortic valve and mitral valve function

  3, 6 and 12 months

• Left anterior descending artery patency

  12 months

• Presence of radiation pneumonitis

  12 months

• Development of complete heart block, atrial or ventricular arrhythmias

  3, 6 and 12 months

Study Arms (1)

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

Device: Stereotactic body radiation therapy

Interventions

Stereotactic body radiation therapy DEVICE

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

Stereotactic body radiation therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Barts Cardiovascular CTU (Queen Mary University of London): collaborator
• Barts Clinical Trial Unit: collaborator

Study Sites (1)

Barts Heart Centre

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Costas O'Mahony, FRCP, MD

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: January 7, 2020
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)