Whole Heart Radiotherapy for End-stage Heart Failure

NCT06299176 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: ESHF-WHRT (2024-10362)
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

End-stage heart failure (ESHF) causes recurrent hospitalizations, cardiac arrhythmias, and intolerance to standard HF therapies are common as the disease progresses. Management focuses on controlling symptoms, correcting precipitants, avoiding triggers, and improving quality-of-life. The combination of recent preclinical and clinical data suggests that localized cardiac RT is relatively safe and has positive conductive and anti-proliferative effects in the "sick" heart. In this Phase 1 study, the investigators aim to assess the feasibility and safety of 5 Gy whole heart radiotherapy in six (6) ESHF participants with limited options for further medical therapy to control their disease. The investigators hypothesize that 5 Gy whole heart radiotherapy can improve LVEF and decrease blood markers of heart failure and inflammation including B-type natriuretic peptide (BNP), C-reactive protein (CRP), and troponins, while also having a very tolerable side effect profile.

Conditions

Heart Failure NYHA Class III; Heart Failure NYHA Class IV; End-stage Heart Failure; Heart Failure With Reduced Ejection Fraction

Keywords

radiation therapy; radiotherapy; radiation; heart failure; cardiac radioablation; left ventricle ejection fraction

Outcome Measures

Primary Outcomes (1)

• Acute adverse events definitely or probably related to radiation therapy at 30 days as per CTCAE v 5.0

  Safety Endpoint

  30 days

Secondary Outcomes (14)

• Overall survival

  6 months

• Hospital stays

  6 months

• Subacute adverse events

  30-90 days after treatment

• Late adverse events

  90 days to 6 months after treatment

• Medication Changes - dose

  6 months

Study Arms (1)

Whole Heart Radiation Therapy

EXPERIMENTAL

Whole heart radiotherapy, 5 Gy in 1 fraction

Other: Whole Heart Radiation Therapy

Interventions

Whole Heart Radiation Therapy OTHER

Radiation to the whole heart in one treatment with a prescribed dose of 5 Gy.

Whole Heart Radiation Therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age ≥ 18
• End-stage heart failure with NYHA class 3 or 4,
• LVEF ≤ 30%
• NT-Pro-BNP ≥ 1500 pg/mL
• on maximum medical therapy with progressive symptoms/disease as defined by their primary cardiologist and ineligible for advanced therapies including left ventricular assist devices and heart transplant

You may not qualify if:

• previous RT in the treatment field that precludes further RT
• active connective tissue disease
• interstitial pulmonary fibrosis
• Participants who are unable to be positioned in a manner where treatment can be safely delivered

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A3J1, Canada

Location

Related Publications (29)

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Ian J Gerard, MD, PhD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Tarek Hijal, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Martin L Bernier, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Tarek Hijal, MD

Model Details: 6 participants with end-stage heart failure (NYHA 3 or 4, LVEF \< 30%) with no other standard of care therapy options to receive whole heart radiation therapy.

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: March 7, 2024
• Study Start: April 30, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)