RBR-5q4gm5b
Recruiting
Phase 3
Double-blind, randomized, controlled study on the effect of Sacubitril/Valsartan in the prevention of cardiotoxicity in high-risk patients undergoing chemotherapy with anthracyclines
Hospital Erasto Gaertner0 sitesMarch 7, 2022
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Hospital Erasto Gaertner
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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