Ventricular Tachycardia
Conditions
Brief summary
This is a research study that aims to understand if giving a lower dose of treatment all at once is as effective and safe as dividing it into three smaller doses for patients with a heart condition called refractory ventricular tachycardia (VT). These patients have not exhibited positive responses to conventional medications or procedures. This study aims to explore whether an alternative approach could yield more beneficial outcomes.
Detailed description
Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder that arises from areas of diseased tissue in the heart. Treatment of VT can involve anti-arrhythmic drugs and catheter-based ablations. Unfortunately, despite multiple antiarrhythmic drugs, as well as the catheter-based ablation procedures, VT continues to persist in your case. At this point in time, The investigators believe that stereotactic body radiotherapy (SBRT) remains the only possible option to potentially treat VT. The investigators hypothesize that by administering SBRT at different dose levels and fractionation may achieve a better therapeutic ratio, defined as comparable efficacy with less risk of toxicity due to lower dose exposure to the normal tissue, including the heart vasculature, in patients when compared to VT patients who receive a dose of 25Gy in a single fraction which is the current treatment option. This is a randomized dose de-escalation trial where the patients will be randomized in in one of the two experimental arms, receiving 1 single fraction OR 3 daily consecutive fractions of RT, and will be treated into a prespecified dose level group, based on the study development. The study includes three de-escalated consecutive dose level groups for each of two randomized treatment arms and there will be 3 patients per group and each group will receive a particular radiation treatment either as single treatments or three treatments. The purpose of this treatment is to safely reduce episodes of VT.
Interventions
RADIATIONRadiation Therapy
Group 1 (3 participants) - will receive a dose of 20 Gy ("Gray", a measurement of radiation) in a single study intervention (one study intervention day)
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
If participants are randomized to either Arm 1 or Arm 2, participants will be in one of the three groups. Each group will enroll 3 participants, based on a criteria of consecutive enrollment over time. After 6 weeks from the last treated participant in Group 1, there will be a review of safety and efficacy of the study intervention in the treated participants before enrolling participants in the next group. This review will continue until the 3rd participant in Group 3 is enrolled and treated. Subsequently the protocol will then move into the follow up phase.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Structural heart disease: 1. Ischemic cardiomyopathy 2. Non-ischemic cardiomyopathy 3. Hypertrophic cardiomyopathy * Refractory VT severity: 1. VT leading to ICD shock with minimum 3 episodes in any 3-month period without reversible cause; 2. Failed or intolerant to antiarrhythmic drug therapy (either amiodarone or ≥ 2 AADs) AND failed ablation (CA) 3. OR ablation (CA) contraindicated * Ability to understand study protocol and to write informed consent * Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements * Expected to remain available for at least 36 months after enrollment
Exclusion criteria
* Age \< 18 years * Pregnancy * Prior chest radiation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes | 6 months before treatment | — |
| Number of treatment-related serious adverse events (SAEs) | 6 weeks post treatment | Safety: SAEs rate ≤ 30% defined using Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0) that could be treatment-related (possibly, probably, or definitely related to treatment) at 6 weeks after treatment is considered clinically acceptable. The SAEs are defined as any grade 3 toxicity requiring hospitalization or any grade 4 to 5 toxicity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of ventricular tachycardia (VT) episodes | 3 months post | — |
| Number of subacute treatment side-effects | 3 months post | Subacute treatment side effects, defined as any grade according to CTCAE criteria (version 5.0) |
| Number of late Adverse events | 1 year post | Long term treatment side effects, defined as any grade according to CTCAE criteria (version 5.0) |
| Overall survival | 1 year post | Overall survival, defined as time calculated from treatment to death for any cause; |
| Recurrence free survival | 3 months post | Recurrence free survival, defined as "time to VT storm" with VT storm defined as ≥ 3 VT/VF episodes leading to ICD therapy within 24 hours |
| Number of incidents of implantable cardiac device (ICD) shock | 3 months before treatment | — |
| Number of Anti-Arrhythmic Drugs (AADs) administration | 3 months before treatment | Any reduction in Anti-Arrhythmic Drugs (AADs) administration |
Countries
United States
Contacts
CONTACTFabiana Gregucci, M.D.
CONTACTFereshteh Talebi, M.D.
PRINCIPAL_INVESTIGATORSilvia Formenti, M.D.
Weill Medical College of Cornell University
Outcome results
None listed