Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial
1.1 Primary Aim
To determine the impact of a two-year course of low-dose carvedilol on surrogate echocardiographic indices of heart failure (HF) risk, including:
¿ Left Ventricular (LV) Posterior Wall Thickness-Dimension Ratio (LV T-D) a wellestablished index of early myocardial remodeling and subsequent HF risk (primary endpoint).
¿ LV systolic and diastolic function, and afterload ¿ established echocardiographic
indices associated with HF risk.
¿ Natriuretic peptides, troponins, and Galectin-3 - circulating biomarkers associated
with myocardial injury, and HF risk.
1.2 Secondary Aims
1.2.1 To establish safety and tolerability of this two-year course of low-dose carvedilol, assessing both objective measures (hepatic function) and patient reported outcomes.
1.2.2 To examine the modifying effect of demographic, clinical, and molecular characteristics on the risk: benefit ratio from this two-year carvedilol intervention.
1.3 Exploratory Aim To evaluate the long-term efficacy of carvedilol in preventing cardiomyopathy and/or heart failure in high-risk childhood cancer survivors.