sacubitril/valsartan
DrugTarget dose 97/103 mg b.i.d .
Other names: Entresto®
NCT Number: NCT03760588
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.
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Notify Me18 year and older
Female
Interventional
Phase 2
Akershus University Hospital, Lørenskog, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Target dose 97/103 mg b.i.d .
Other names: Entresto®
Time frame: From randomization to end of blinded therapy (18 months)
Time frame: From randomization to end of blinded therapy (18 months)
Time frame: From randomization to end of blinded therapy (18 months)
Time frame: From randomization to end of blinded therapy (18 months)
Time frame: From randomization to end of blinded therapy (18 months)
Time frame: From randomization to end of blinded therapy (18 months)
An absolute reduction in LVEF ≥ 5% by CMR or a relative percentage reduction of global longitudinal strain (GLS) > 15%
Time frame: From randomization to end of blinded therapy (18 months)
Absolute reduction in LVEF ≥ 10% to a value below 50% as measured either by CMR or Echocardiography, or incidence of clinical heart failure
Time frame: From randomization to end of blinded therapy (18 months)
Cardiac biomarkers defined as cardiac troponins I and T measured by high sensitivity assays (hs-TnI and hs-TnT) and N-terminal proB-type natriuretic peptide (NT-proBNP)
Time frame: From randomization to end of blinded therapy (18 months)
Torbjorn Omland
Other
PRevention of cArdiac Dysfunction During Adjuvant Breast Cancer Therapy: A Randomized, Placebo-controlled, Multicenter Trial
Acronym: PRADAII
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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