protocolSection identificationModule nctId: NCT06299176, orgStudyIdInfo id: ESHF-WHRT (2024-10362), briefTitle: Whole Heart Radiotherapy for End-stage Heart Failure, acronym: ESHF-WHRT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Heart Failure NYHA Class III, conditions: Heart Failure NYHA Class IV, conditions: End-stage Heart Failure, conditions: Heart Failure With Reduced Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: no masking, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Whole Heart Radiation Therapy, outcomesModule primaryOutcomes measure: Change in mean left ventricle ejection fraction, primaryOutcomes measure: Acute adverse events definitely or probably related to radiation therapy at 30 days as per CTCAE v 5.0, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Hospital stays, secondaryOutcomes measure: Subacute adverse events, secondaryOutcomes measure: Late adverse events, secondaryOutcomes measure: Medication Changes - dose, secondaryOutcomes measure: Medication Changes - number, secondaryOutcomes measure: Quality of life CHFQOLQ-20, secondaryOutcomes measure: Quality of life - SF-36, secondaryOutcomes measure: Troponin changes, secondaryOutcomes measure: Lactate changes, secondaryOutcomes measure: Renal Function, secondaryOutcomes measure: b-natrurietic peptide, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False