Heart Failure
Conditions
Interventions
Experimental group: 50 patients with cancer undergoing chemotherapy with anthracycline who presented an increase in ultrasensitive troponin above the 99th percentile during treatment. These patients w
Sponsors
Hospital Erasto Gaertner
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Brazil
Contacts
Public ContactMarcely Bonatto
Erasto Gaertner Hospital
Outcome results
None listed