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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

Awards & highlights

Study 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

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,210 Total Patients Enrolled

15 Trials studying Cancer Survivors

3,651 Patients Enrolled for Cancer Survivors

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,903 Total Patients Enrolled

70 Trials studying Cancer Survivors

17,301 Patients Enrolled for Cancer Survivors

Saro Armenian, DO, MPHPrincipal InvestigatorCity of Hope Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does the FDA's position on carvedilol currently stand?

"Because there is only data confirming carvedilol's safety and no efficacy, it received a score of 2."

Answered by AI

Are new participants needed for this ongoing research project?

"The study in question is not searching for patients at the moment, as evidenced by its last edit date of 3/29/2022. However, there are 819 other clinical trials that are still recruiting patients."

Answered by AI

For what medical conditions is carvedilol most often prescribed?

"Carvedilol is a medication most frequently used to treat hypertension, but can also be effective in treating heart failure, hypesthesia, and left ventricular dysfunction."

Answered by AI

By how many different people is this trial being managed?

"There are 4 clinical trial sites enrolling patients for this study. They are located in Toronto, Duarte, Ann Arbor as well other cities. If you decide to participate in the trial, please try and select the closest site to you so that travel isn't too demanding."

Answered by AI

Is this the first time carvedilol has been trialed?

"As of right now, there are 29 active clinical trials for carvedilol underway with 7 in Phase 3. Although a few of the trials are taking place in Orlando, Florida, there are 978 research centres running tests for carvedilol worldwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2012. "Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Congestive Heart Failure (PREVENT-CHF): A Phase IIB Randomized Placebo-Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01347970.

All > Heart Failure With Preserved Ejection Fraction > Congestive Heart Failure