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PRevention of cArdiac Dysfunction During Adjuvant Breast Cancer Therapy: A Randomized, Placebo-controlled, Multicenter Trial
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Akershus University Hospital
Lørenskog, Norway
Stavanger University Hospital
Stavanger, Norway
University of North Norway
Tromsø, Norway
St Olavs Hospital
Trondheim, Norway
Start Date
January 31, 2019
Primary Completion Date
September 5, 2024
Completion Date
September 5, 2024
Last Updated
February 12, 2025
138
ACTUAL participants
Sacubitril/valsartan
DRUG
Lead Sponsor
Torbjorn Omland
Collaborators
NCT07484009
NCT07191730
Data Source & Attribution
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