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Cardioprotectant

Dexrazoxane for Congenital Heart Defects

Phase 1
Waitlist Available
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days
Awards & highlights

Summary

This trial is testing Dexrazoxane, a heart-protecting drug, in newborns and young infants having heart surgery. These young patients are at high risk for heart damage during surgery. The drug aims to reduce harmful substances and prevent cell death to protect the heart. Dexrazoxane has been studied for its heart-protective effects, particularly in patients undergoing cancer treatment.

Eligible Conditions
  • Congenital Heart Defects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration vs time curve (AUC)
Minimum plasma concentration (Cmin)
Peak Plasma Concentration (Cmax)
+1 more
Secondary outcome measures
Composite outcome for neonatal cardiac surgery
Hospital Length of Stay
ICU Length of Stay
+7 more

Side effects data

From 2022 Phase 2 trial • 73 Patients • NCT02584309
100%
Anemia
100%
Alopecia
90%
Lymphocytes decreased
80%
Nausea
70%
Fatigue
70%
Hypocalcemia
60%
Constipation
60%
Hypokalemia
50%
Creatinine increased
50%
Alkaline phosphatase increased
50%
Anxiety
40%
White blood cell decreased
40%
Headache
30%
Febrile neutropenia
30%
Diarrhea
30%
Mucositis oral
30%
Neutrophil count decreased
30%
Platelet count decreased
30%
Hypernatremia
30%
Hyponatremia
30%
Bone pain
20%
Fever
20%
Hyperglycemia
20%
Flushing
20%
Hypertriglyceridemia
20%
Hypoalbuminemia
20%
Back pain
20%
Pain in extremity
20%
Peripheral sensory neuropathy
20%
Thromboembolic event
10%
Abdominal pain
10%
Respiratory failure
10%
Sinus bradycardia
10%
Oral dysethesia
10%
Stomach pain
10%
Vomiting
10%
Flu like symptoms
10%
Lung infection
10%
Pharyngitis
10%
Anorexia
10%
Myalgia
10%
Sinus pain
10%
Spasticity
10%
Proteinuria
10%
Dyspnea
10%
Hoarseness
10%
Nasal congestion
10%
Pruritus
10%
Rash acneiform
10%
Sinus tachycardia
10%
Edema limbs
10%
Rash pustular
10%
Wound complication
10%
Fracture
10%
Alanine aminotransferase increased
10%
INR increased
10%
Hypercalcemia
10%
Hypermagnesemia
10%
Chest wall pain
10%
Myositis
10%
Depression
10%
Hematuria
10%
Hypotension
10%
Pneumothorax
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)
Arm 1: Doxorubicin and Upfront Dexrazoxane

Trial Design

1Treatment groups
Experimental Treatment
Group I: DexrazoxaneExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexrazoxane
FDA approved

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
359 Previous Clinical Trials
81,741 Total Patients Enrolled
Dell Children's Medical Center of Central TexasOTHER
6 Previous Clinical Trials
5,004,411 Total Patients Enrolled
~3 spots leftby Sep 2025
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