Phase 2Recruiting
High Cardiovascular Risk Intervention With Cardio-Oncology Consultation for Prostate Cancer Following Androgen Receptor Pathway Inhibitor (ARPI) Therapy (Heart-Safe)
- Sponsor
- Cedars-Sinai Medical Center (Academic or other)
- Enrolment
- 80 planned
- Conditions
- Prostate Cancer (Diagnosis); Prostate Cancer Stage IV; CV Risk
- Interventions
- Cardio-Oncology Referral; Notification to PCP/General Cardiologist
- Ages
- adults, older adults
- Registry
- NCT07223385
From the registry
In patients with prostate cancer (PC), cardiovascular disease (CVD) causes significant morbidity and is the second leading cause of death. Both pre-existing CVD and the use of androgen deprivation therapy (ADT)-a key cornerstone of treatment for men with locally advanced or metastatic PC1,2 contribute to increased CV risk. ADT has been associated with adverse metabolic effects, including increased central adiposity, elevated low-density lipoprotein (LDL) levels, impaired glycemic control, and arterial wall remodeling and endothelial dysfunction The data demonstrates that for most patients, the status quo is insufficient6 and there remains a critical gap in the early identification of high CV-risk PC patients who may benefit most from aggressive risk mitigation strategies. Mitigation strategies, like the addition of statins as primary prevention, have shown decrease in MI/CHD death across thousands of patients. Age-related expansion of hematopoietic clones carrying recurrent somatic mutations, termed clonal hematopoiesis of indeterminate potential (CHIP) has recently been identified…
Primary outcomes
- Rate of any CV medication Initiation and/or Change