Sacubitril/Valsartan in PriMAry preventIoN of the cardiotoxicity of systematic breaST canceR trEAtMent. Randomized, multicenter, double-blind, placebo-controlled study.

Conditions

Heart failure – post-anthracycline cardiomyopathy

Brief summary

Decrease in left ventricular ejection fraction ≥ 5% assessed on magnetic resonance imaging (MRI) in 24 months from randomisation

Detailed description

Death from any cause or hospitalization for heart failure, Death from any cause, Death from cardiovascular causes, Hospitalization for other cardiovascular causes, cardiotoxicity, Decrease in left ventricular ejection fraction ≥ 5% (MRI) during 24 months from randomization, Decrease in left ventricular ejection fraction ≥ 5% during 24 months from randomization, Occurrence of diastolic dysfunction (UKG) within 24 months of randomization Diastolic dysfunction assessed on echocardiography, Development of pathological pericardial fluid volume or increase in pericardial fluid volume from baseline, Occurrence of cardiac tamponade, Occurrence of pericarditis, Occurrence of myocarditis, Development of ventricular arrhythmias, Development of supraventricular arrhythmias, Presence of conduction disturbances, Changes in corrected QT interval, Changes in BNP, NT pro-BNP, troponin T or troponin I levels

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGEntresto 97 mg/103 mg film-coated tablets

DRUGEntresto 49 mg/51 mg film-coated tablets

DRUGplacebo Entresto 49 mg / 51mg

DRUGplacebo Entresto 97 mg / 103 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Decrease in left ventricular ejection fraction ≥ 5% assessed on magnetic resonance imaging (MRI) in 24 months from randomisation	—

Secondary

Measure	Time frame
Death from any cause or hospitalization for heart failure, Death from any cause, Death from cardiovascular causes, Hospitalization for other cardiovascular causes, cardiotoxicity, Decrease in left ventricular ejection fraction ≥ 5% (MRI) during 24 months from randomization, Decrease in left ventricular ejection fraction ≥ 5% during 24 months from randomization, Occurrence of diastolic dysfunction (UKG) within 24 months of randomization Diastolic dysfunction assessed on echocardiography, Development of pathological pericardial fluid volume or increase in pericardial fluid volume from baseline, Occurrence of cardiac tamponade, Occurrence of pericarditis, Occurrence of myocarditis, Development of ventricular arrhythmias, Development of supraventricular arrhythmias, Presence of conduction disturbances, Changes in corrected QT interval, Changes in BNP, NT pro-BNP, troponin T or troponin I levels	—

Measure

Time frame

Death from any cause or hospitalization for heart failure, Death from any cause, Death from cardiovascular causes, Hospitalization for other cardiovascular causes, cardiotoxicity, Decrease in left ventricular ejection fraction ≥ 5% (MRI) during 24 months from randomization, Decrease in left ventricular ejection fraction ≥ 5% during 24 months from randomization, Occurrence of diastolic dysfunction (UKG) within 24 months of randomization Diastolic dysfunction assessed on echocardiography, Development of pathological pericardial fluid volume or increase in pericardial fluid volume from baseline, Occurrence of cardiac tamponade, Occurrence of pericarditis, Occurrence of myocarditis, Development of ventricular arrhythmias, Development of supraventricular arrhythmias, Presence of conduction disturbances, Changes in corrected QT interval, Changes in BNP, NT pro-BNP, troponin T or troponin I levels

—

Countries

Poland

Outcome results

None listed