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Beta Blocker
carvedilol for Cancer Survivors
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
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 moreTrial 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
599 Previous Clinical Trials
1,923,292 Total Patients Enrolled
15 Trials studying Cancer Survivors
3,651 Patients Enrolled for Cancer Survivors
National Cancer Institute (NCI)NIH
13,907 Previous Clinical Trials
41,011,894 Total Patients Enrolled
70 Trials studying Cancer Survivors
17,212 Patients Enrolled for Cancer Survivors
Saro Armenian, DO, MPHPrincipal InvestigatorCity of Hope Medical Center
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