Table 2.
Ongoing pharmacological and lifestyle cardioprotection trials.
| Trial Name (PI) | Trial Intervention | Population | Primary Outcomes |
|---|---|---|---|
| Pharmacological Interventions | |||
| PREVENT (NCT01988571) (Hundley, Wake Forest) | Statins (Atorvastatin) vs. Placebo | Breast cancer, lymphoma, chemotherapy with anthracyclines | MRI, biomarkers, symptoms at 2 years |
| STOP-CA (NCT02943590) (Neilan, Scherrer Crosbie, MGH) |
Statins vs. Placebo | Non-Hodgkin’s Lymphoma, chemotherapy with anthracyclines | MRI, echo at 12 months |
| SWOG S1501 (NCT03418961) (Floyd, Leja, Fabian, SWOG) | Carvedilol vs. No Intervention | Metastatic HER2+ breast cancer | Time to first indication of cardiac dysfunction as measured by changes in LVEF by echo |
| ICOS-ONE (NCT01968200) (Cipolla, European Institute of Oncology) |
Enalapril preventatively vs. After indication of cardiotoxicity | Cancer, chemotherapy with anthracyclines | Cardiac troponin level elevation above threshold |
| PROACT (NCT03265574) (Change, Newcastle University) | Enalapril vs. No Intervention | Post-surgical breast cancer to be treated with epirubicin | Cardiac troponin T release during epirubicin treatment |
| CARDIAC CARE (ISRCTN24439460) (Maclean, The Queen’s Medical Research Institute) | Angiotensin Receptor Blockers and B-blocker or No Intervention | Breast cancer, chemotherapy with anthracyclines, increased cardiac troponin levels | MRI at 6 months |
| PRADA II (NCT03760588) (Omland, Gulati) | Entresto vs. Placebo | Breast cancer, chemotherapy with anthracyclines | Left ventricular ejection fraction by cardiovascular magnetic resonance at 18 months |
| Lifestyle Interventions | |||
| EQUAL (NCT02244411) (Tonorezos) | Web-based diet and activity intervention | Adult aged, obese survivors of childhood acute lymphoblastic leukemia | Weight loss at 2 years |
|
NCT03223753 (Ness) |
Web-based physical activity intervention | Childhood acute lymphoblastic leukemia patients within 3 months of completing therapy | Physiologic cost index at 6 months |
|
NCT03104543 (Chow) |
Survivorship care plan counseling intervention | Adult-aged survivors at high risk of cardiovascular disease | Blood pressure, cholesterol, glucose, and lipids at 1 year |
|
NCT03386383 (Valle) |
Mobile intervention with tailored feedback | Young adult (18–39) cancer survivors | Physical activity (ActiGraph) |
| CARDAPAC (NCT02433067) (Mougin-Guillaume) | Three months individualized physical activity (45 min, 3 times per week) | HER2+ breast cancer patients treated only by trastuzumab | LVEF, body composition, muscle function, metabolic, hormonal and inflammatory responses, pain, fatigue, quality of life |
PREVENT: Preventing Anthracycline Cardiovascular Toxicity with Statins; STOP-CA: Statins to Prevent the Cardiotoxicity from Anthracyclines; SWOG: Southwest Oncology Group; ICOS-ONE: The International CardioOncology Society-One Trial; PROACT: Preventing Cardiac Damage in Patients Treated for breast Cancer: A Phase 3 Randomized, Open Label, Blinded Endpoint, Superiority Trial of Enalapril to Prevent Anthracycline-induced CardioToxicity; CARDIAC CARE: The Cardiac CARE Trial—can heart muscle injury related to chemotherapy be prevented?; EQUAL: Exercise and Quality Diet After Leukemia: The Equal Study; CARDAPAC: Physical Activity Intervention on Myocardial Function in Patients with HER2 + Breast Cancer.