Prevention of Cardiac Dysfunction During Breast Cancer Therapy
Status:
Recruiting
Trial end date:
2025-09-14
Target enrollment:
Participant gender:
Summary
Breast cancer is the most common cancer among women. The modern post-surgery treatment with
chemotherapy, immunotherapy, radiation and hormone therapy has improved the overall 5-years
survival drastically. However, an unwanted effect of the post-surgery treatment is its
potentially deleterious effect on the heart resulting in cardiac dysfunction. Angiotensin
antagonists are used as part of the heart failure treatment. In smaller studies angiotensin
antagonists have shown to have a cardioprotective effect during breast cancer treatment.
Sacubitril/valsartan is a potent drug that in addition to an angiotensin antagonist contains
a neprilysin inhibitor. Sacubitril/valsartan has proved to be superior to enalapril in
chronic heart failure. In this randomized placebo controlled double blind trial we
hypothesize that sacubitril/valsartan used concomitantly during anthracycline containing
chemotherapy for breast cancer treatment prevents cardiac dysfunction as measured by cardiac
magnetic resonance imaging (CMR). PRADA II is a Norwegian multicenter trial intending to
recruit 214 patients and follow them for 18 months with CMR, cardiac ultrasound, blood
samples, functional capacity tests and health related quality of life questionnaires.
Phase:
Phase 2
Details
Lead Sponsor:
Torbjorn Omland
Collaborators:
Helse Stavanger HF Klinbeforsk Norwegian Cancer Society Novartis Oslo University Hospital St. Olavs Hospital University Hospital of North Norway University Hospital, Akershus