PREVENT: Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Congestive Heart Failure (PREVENT-CHF): A Phase IIB Randomized Placebo-Controlled Trial

Categories:

Long-term Effects

Phase I/II

Diseases Treated:

Congestive heart failure

Eligibility Overview:

  • Participant is > 16 years of age.
  • Participant had cancer diagnosis < 21 years of age.
  • Participant has lifetime cumulative anthracycline dose > 300 mg/m2.
  • Participant is > 2 years since completion of treatment for cancer.

Description

Anthracyclines are chemotherapy drugs commonly used in the treatment of many childhood cancers. High doses of anthracyclines are known to increase the risk of heart muscle weakness (cardiomyopathy) and congestive heart failure. This study is designed to measure what effect taking low-dose Carvedilol for two years might have on preventing the heart muscle changes that can lead to cardiomyopathy and congestive heart failure. Survivors of childhood cancers who received 300 mg/m2 or more of anthracyclines will be randomly (like tossing a coin) assigned to take a low dose of Carvedilol or an identical looking pill which contains no medicine (placebo).

Objectives

  • To learn if taking a low dose of Carvedilol for two years prevents the heart muscle changes that can lead to cardiomyopathy and congestive heart failure in survivors of childhood cancer treated with high doses of anthracycline chemotherapy.
  • To learn how well low-dose Carvedilol is tolerated in survivors of childhood cancer treated with high doses of anthracycline chemotherapy.
  • To learn about the side effects of Carvedilol in survivors who were treated with high doses of anthracycline chemotherapy.

Eligibility

  • Participant is > 16 years of age.
  • Participant had cancer diagnosis < 21 years of age.
  • Participant has lifetime cumulative anthracycline dose > 300 mg/m2.
  • Participant is > 2 years since completion of treatment for cancer.
  • Participant is not receiving treatment for cardiomyopathy or congestive heart failure.
  • Participant’s heart rate is > or equal to 60 beats per minute.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Melissa M. Hudson MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.