The effect of Sacubitril/Valsartan in preventing heart disease in high-risk patients undergoing chemotherapy with anthracyclines

Phase 3

Recruiting

• Conditions: Heart Failure; Anthracyclines; Cardiotoxicity; C14.280

• Registration Number: RBR-5q4gm5b
• Lead Sponsor: Hospital Erasto Gaertner

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-07
• Last Update Posted: 29 May 2023
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients diagnosed with cancer who will undergo chemotherapy with anthracyclines and who have an increase in ultrasensitive troponin I above the 99th percentile after any chemotherapy session; age over 18 years; patients who sign the Free and Informed Consent Term

Exclusion Criteria

Inability to analyze ventricular function; claustrophobia; history of chemotherapy or radiotherapy; previous symptoms of heart failure; presence of cardiomyopathy ou coronary artery disease; moderate to severe aortic or mitral valve disease; contraindication to the use of Sacubitril/Valsartan such as a history of angioedema, renal artery stenosis; creatinine clearance <30ml/min/m2; serum potassium >5.0mEq/L; pregnant women; systolic blood pressure <100mmHg; use of angiotensin converting enzyme inhibitor, angiotensin receptor blocker, Sacubitril/Valsartan, or beta-blocker; implantation of pacemaker not compatible with MRI; patients with HER 2 expression; patients with frailty or at medium-high risk of hospitalization with substantial change in chemotherapy regimen

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in strain >15% compared to baseline, after 24 weeks of use of Sacubitril/valsartan in patients undergoing chemotherapy with anthracyclines, who have myocardial injury determined by an increase in ultrasensitive troponin above the 99th percentile

Secondary Outcome Measures

Name	Time	Method
Aumento de troponina ultrassensível e NT pró-BNP após 06 meses de tratamento; Variação da fração de ejeção, dilatação de câmaras cardíacas, alterações dos parâmetros de função diastólica e de massa ventricular pelo ecocardiograma e pela ressonância nuclear magnética após 06 meses de tratamento; queda de fração de ejeção>10% com valor final <53%, pelo ecocardiograma e pela ressonância nuclear magnética após 06 meses de tratamento; variação do strain pelo ecocardiograma após 06 meses de tratamento; alterações de matriz extracelular e fibrose intersticial pela ressonância nuclear magnética após 06 meses de tratamento; incidência de insuficiência cardíaca sintomática, hospitalizações, necessidade de transplante ou morte após 06 meses de tratamento; ocorrência de qualquer efeito adverso relacionados a medicação após 06 meses de tratamento<br><br>