drugset / Trial / NCT04190433

Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial

NCT04190433

RandomizedParallel-groupDouble-blindSupportive care

Summary

This phase II trial compares two drug therapy plans for the correction of heart function changes (reduced ejection function) in patients who have undergone anthracycline-based treatment for lymphoma, sarcoma, or breast cancer. "Reduced ejection fraction" means the left ventricle of the heart is pumping a reduced blood volume with each heartbeat. Treatment is recommended, and the purpose of this research is to compare two different drug therapy plans (standard therapy with carvedilol and lisinopril and standard therapy with carvedilol and lisinopril plus pravastatin and spironolactone) and their effects on improvement of heart function. All of these drugs are heart medications, and carvedilol and lisinopril are commonly used to improve heart function. Adding pravastatin, a cholesterol lowering drug with additional beneficial effects on the cardiovascular system, and spironolactone, a water pill with additional beneficial effects on the cardiovascular system, may lead to even better (and faster) improvements in heart function.

Timeline

Start
2020-09-01
Primary completion
2023-04-18
Completion
2023-04-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Pravastatin Small molecule Oral
Subject Spironolactone Small molecule Oral
Background Carvedilol Other / unclassified Oral
Background LISINOPRIL ANHYDROUS Small molecule Oral