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Clinical study of stereotactic radiation ablation therapy for hypertrophic cardiomyopathy

Clinical study of stereotactic radiation ablation therapy for hypertrophic cardiomyopathy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053123
Enrollment
Unknown
Registered
2021-11-12
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic cardiomyopathy

Interventions

Experimental 1 group:The prescribed dose of 25Gy was designed for radiotherapy planning
Experimental 2 group:A radiotherapy plan was designed at a prescribed dose of 27 to 35Gy

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged over 60 years, no gender limit; 2.The multidisciplinary team diagnosed hypertrophic obstructive cardiomyopathy, and cardiac imaging revealed that the thickness of the basal segment of the ventricular septum was >=15mm; 3.There are still symptoms after treatment with the maximum tolerated dose of the drug recommended by the guide, NYHA III-IV, or CCS III-IV, or repeated syncope and it is considered to be mainly caused by left ventricular outflow tract obstruction; 4.Transthoracic echocardiography measures left ventricular outflow tract pressure difference >=50 mmHg at rest or under load; 5.Anatomy is not suitable for surgical ventricular septal volume reduction and transcatheter chemical ablation of the ventricular septum, or the aforementioned treatment methods have failed, or the surgical operation risk is high; 6.The anatomical structure of the patient was assessed by a multidisciplinary team to be suitable for ventricular septal stereotactic radiotherapy; 7.Able to provide informed consent; 8.Able to complete the follow-up strictly according to the study plan.

Exclusion criteria

Exclusion criteria: 1.Hypertrophic non-obstructive cardiomyopathy; 2.Diffuse left ventricular myocardial hypertrophy, severely impaired diastolic function, and expected symptom relief after ventricular septal obstruction is relieved; 3.Combine diseases that require cardiac surgery at the same time; 4.Untreated severe coronary artery stenosis requires revascularization; 5.Acute myocardial infarction or stroke occurred within 4 weeks before radiotherapy; 6.Have undergone coronary interventional surgery, vascular interventional or cardiac surgery within 4 weeks before radiotherapy; 7.There are other diseases that seriously affect the quality of life, such as chronic liver and kidney failure, severe neurological diseases, severe metabolic diseases, etc., after comprehensive evaluation by a multidisciplinary team, it is considered unsuitable for ventricular septal stereotactic radiotherapy; 8.There are contraindications to magnetic resonance, if a permanent pacemaker has been implanted; 9.Life expectancy <12 months.

Design outcomes

Primary

MeasureTime frame
Left ventricular outflow tract differential pressure;The thickness of the myocardial;

Secondary

MeasureTime frame
Degree of myocardial fibrosis;Overall survival and quality of life;

Countries

China

Contacts

Public ContactChen Mao

West China Hospital, Sichuan University

hmaochen@vip.sina.com+86 18980602046

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026