Asset Details
Do you wish to reserve the book?
Rationale and design of the Children’s Oncology Group (COG) study ALTE1621: a randomized, placebo-controlled trial to determine if low-dose carvedilol can prevent anthracycline-related left ventricular remodeling in childhood cancer survivors at high risk for developing heart failure
Hey, we have placed the reservation for you!
By the way, why not check out events that you can attend while you pick your title.
Oops! Something went wrong.
Looks like we were not able to place the reservation. Kindly try again later.
Are you sure you want to remove the book from the shelf?
Rationale and design of the Children’s Oncology Group (COG) study ALTE1621: a randomized, placebo-controlled trial to determine if low-dose carvedilol can prevent anthracycline-related left ventricular remodeling in childhood cancer survivors at high risk for developing heart failure
Do you wish to request the book?
Rationale and design of the Children’s Oncology Group (COG) study ALTE1621: a randomized, placebo-controlled trial to determine if low-dose carvedilol can prevent anthracycline-related left ventricular remodeling in childhood cancer survivors at high risk for developing heart failure
Please be aware that the book you have requested cannot be checked out. If you would like to checkout this book, you can reserve another copy
We have requested the book for you!
Your request is successful and it will be processed during the Library working hours. Please check the status of your request in My Requests.
Oops! Something went wrong.
Looks like we were not able to place your request. Kindly try again later.
Journal Article
Rationale and design of the Children’s Oncology Group (COG) study ALTE1621: a randomized, placebo-controlled trial to determine if low-dose carvedilol can prevent anthracycline-related left ventricular remodeling in childhood cancer survivors at high risk for developing heart failure
2016
Overview
Background
Anthracyclines are widely used in the treatment of childhood cancer. One of the well-recognized side-effects of anthracycline therapy is dose-dependent cardiomyopathy that may progress to heart failure (HF) years after completion of cancer-directed therapy. This study will evaluate the efficacy of low-dose beta-blocker (carvedilol) for HF risk reduction in childhood cancer survivors at highest risk for HF. The proposed intervention has the potential to significantly reduce chronic cardiac injury via interruption of neurohormonal systems responsible for left ventricular (LV) remodeling, resulting in improved cardiac function and decreased risk of HF. The intervention is informed by previous studies demonstrating efficacy in pediatric and adult non-oncology populations, yet remains unstudied in the pediatric oncology population.
Methods/Design
The primary objective of the trial is to determine impact of the intervention on echocardiographic markers of cardiac remodeling and HF risk, including: LV wall thickness/ dimension ratio (LVWT/D; primary endpoint), as well as LV ejection fraction, volume, and blood biomarkers (natriuretic peptides, galectin-3) associated with HF risk. Secondary objectives are to establish safety and tolerability of the 2-year course of carvedilol using: 1) objective measures: hepatic and cardiovascular toxicity, treatment adherence, and 2) subjective measures: participant self-reported outcomes. Two hundred and fifty survivors of childhood cancer (diagnosed <21 years of age), and previously treated with high-dose (≥300 mg/m
2
) anthracyclines will be enrolled in a randomized, double-blind, placebo controlled trial. After baseline assessments, participants will be randomized in a 1:1 ratio to low-dose carvedilol (maximum dose: 12.5 mg/day) or placebo. Carvedilol or placebo is up-titrated (starting dose: 3.125 mg/day) according to tolerability.
Discussion
When completed, this study will provide much-needed information regarding a physiologically plausible pharmacological risk-reduction strategy for childhood cancer survivors at high risk for developing anthracycline-related HF.
Trial registration
ClinicalTrials.gov;
NCT02717507
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V
Subject
Adrenergic beta-Antagonists - administration & dosage
/ Adrenergic beta-Antagonists - adverse effects
/ Anthracyclines - adverse effects
/ Antibiotics, Antineoplastic - adverse effects
/ Carbazoles - administration & dosage
/ Carbazoles - adverse effects
/ Female
/ Heart Failure - chemically induced
/ Heart Failure - physiopathology
/ Heart Failure - prevention & control
/ Humans
/ Hypertrophy, Left Ventricular - chemically induced
/ Hypertrophy, Left Ventricular - diagnosis
/ Hypertrophy, Left Ventricular - physiopathology
/ Hypertrophy, Left Ventricular - prevention & control
/ Male
/ Medicine
/ Non-coronary artery cardiac disease
/ Propanolamines - administration & dosage
/ Propanolamines - adverse effects
/ Ventricular Dysfunction, Left - chemically induced
/ Ventricular Dysfunction, Left - diagnosis
/ Ventricular Dysfunction, Left - physiopathology
/ Ventricular Dysfunction, Left - prevention & control
