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Beta Blocker

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

Phase 2
Waitlist Available
Led By Saro Armenian, DO, MPH
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months

Summary

This trial looks at the side effects and effectiveness of a low dose of carvedilol in preventing congestive heart failure in young cancer survivors who were exposed to high doses of anthracyclines.

Eligible Conditions
  • Cancer Survivors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
LV thickness-dimension ratio (LV T-D), reported in terms of LV posterior wall dimension in systole and LV dimension based on the internal diameter in diastole
Secondary study objectives
Blood biomarkers of myocardial remodeling and CHF risk, including cardiac troponins (cTn), blood natriuretic peptide (BNP), and galectin-3
Echocardiographic efficacy measures, including afterload and systolic and diastolic measurements
Frequency of individuals with elevated liver function measurements (bilirubin, AST, ALT)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (beta-adrenergic/alpha-1 adrenergic blocker)Experimental Treatment9 Interventions
Patients receive low-dose carvedilol PO QD or BID for 24 months.
Group II: Arm II (placebo)Placebo Group9 Interventions
Patients receive placebo PO QD or BID for 24 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
quality-of-life assessment
2012
Completed Phase 3
~2780
polymorphism analysis
2004
Completed Phase 3
~2700
microarray analysis
2006
Completed Phase 3
~3600
polymerase chain reaction
2006
Completed Phase 2
~1700
carvedilol
2000
Completed Phase 4
~13130

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,197 Total Patients Enrolled
15 Trials studying Cancer Survivors
3,651 Patients Enrolled for Cancer Survivors
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,022,920 Total Patients Enrolled
70 Trials studying Cancer Survivors
17,212 Patients Enrolled for Cancer Survivors
Saro Armenian, DO, MPHPrincipal InvestigatorCity of Hope Medical Center
~18 spots leftby Dec 2025
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