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Beta Blocker

Carvedilol for Preventing Heart Failure in Childhood Cancer Survivors

Phase 2
Waitlist Available
Led By Saro H Armenian
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have had a cancer diagnosis < 22 years of age, irrespective of current age
Patient must have a lifetime cumulative anthracycline dose of >= 250 mg/m^2 DOXOrubicin equivalent without the protection of dexrazoxane (Zinecard) therapy; the anthracycline dose threshold must be met as part of the treatment of a cancer that was diagnosed at < 22 years of age
Must not have
Endocrine disorders (such as primary aldosteronism, pheochromocytoma, hyper- or hypothyroidism) not controlled with medication
Uncontrolled diabetes (controlled diabetes per the American Diabetes Association and International Diabetes Center's Glycemic Target Goals is hemoglobin A1C < 7%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up responses at days 14 to 730 were combined

Summary

This trial tests how well low-dose carvedilol prevents heart failure in cancer survivors who were exposed to high-dose anthracyclines. Carvedilol may help lower the risk of cardiovascular complications.

Who is the study for?
This trial is for childhood cancer survivors who are now at risk of heart failure due to high-dose anthracycline chemotherapy. Participants must weigh at least 40 Kg, have been diagnosed with cancer before age 22, finished treatment at least 2 years ago, and received a certain amount of anthracycline without dexrazoxane protection.
What is being tested?
The study tests if low-dose Carvedilol can prevent heart failure in those exposed to high doses of anthracyclines during childhood cancer treatment. It includes lab biomarker analysis, pharmacogenomic and pharmacological studies, placebo comparison, quality-of-life assessment, and questionnaires.
What are the potential side effects?
Carvedilol may cause side effects such as dizziness or lightheadedness (due to lowered blood pressure), fatigue, digestive issues like nausea or diarrhea, changes in weight or cholesterol levels. Some people might also experience slower heart rates.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was diagnosed with cancer before turning 22.
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I received a high dose of a specific chemotherapy drug for cancer treated before I was 22.
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I weigh at least 40 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My hormone-related condition is not controlled by medication.
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My diabetes is under control with an A1C level below 7%.
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I am currently taking specific medications that affect drug metabolism.
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I am not pregnant and have a negative pregnancy test.
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I have a serious heart rhythm problem.
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I have moderate-to-severe lung problems like asthma that need treatment.
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I do not have severe heart valve problems or thickened heart muscles causing obstruction.
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I am currently being treated for heart issues.
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I have heart rhythm problems not controlled by medication or devices.
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I cannot swallow pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~responses at days 14 to 730 were combined
This trial's timeline: 3 weeks for screening, Varies for treatment, and responses at days 14 to 730 were combined for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average Left-Ventricular Wall Thickness-Dimension Ratio Z-score (LVWT/Dz)
Secondary study objectives
Average Alanine Aminotransferase
Average Aspartate Aminotransferase
Average Bilirubin
+16 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (carvedilol)Experimental Treatment6 Interventions
Patients receive low-dose carvedilol PO QD or BID for 24 months.
Group II: Arm II (placebo)Placebo Group6 Interventions
Patients receive placebo PO QD or BID for 24 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carvedilol
2011
Completed Phase 4
~1410

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
460 Previous Clinical Trials
239,841 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,755 Total Patients Enrolled
2 Trials studying Blood Cancers
112 Patients Enrolled for Blood Cancers
Saro H ArmenianPrincipal InvestigatorChildren's Oncology Group
3 Previous Clinical Trials
1,390 Total Patients Enrolled

Media Library

Carvedilol (Beta Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT02717507 — Phase 2
Blood Cancers Research Study Groups: Arm I (carvedilol), Arm II (placebo)
Blood Cancers Clinical Trial 2023: Carvedilol Highlights & Side Effects. Trial Name: NCT02717507 — Phase 2
Carvedilol (Beta Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02717507 — Phase 2
~20 spots leftby Nov 2025
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