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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02717507
Registration number
NCT02717507
Ethics application status
Date submitted
9/03/2016
Date registered
23/03/2016
Date last updated
9/04/2024
Titles & IDs
Public title
Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors
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Scientific title
Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial
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Secondary ID [1]
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NCI-2016-00232
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Secondary ID [2]
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ALTE1621
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hematopoietic and Lymphoid Cell Neoplasm
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Malignant Solid Neoplasm
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Carvedilol
Other interventions - Laboratory Biomarker Analysis
Other interventions - Pharmacogenomic Study
Other interventions - Pharmacological Study
Other interventions - Placebo Administration
Other interventions - Quality-of-Life Assessment
Other interventions - Questionnaire Administration
Experimental: Arm I (carvedilol) - Patients receive low-dose carvedilol PO QD or BID for 24 months.
Placebo Comparator: Arm II (placebo) - Patients receive placebo PO QD or BID for 24 months.
Treatment: Drugs: Carvedilol
Given PO
Other interventions: Laboratory Biomarker Analysis
Correlative studies
Other interventions: Pharmacogenomic Study
Correlative studies
Other interventions: Pharmacological Study
Correlative studies
Other interventions: Placebo Administration
Given PO
Other interventions: Quality-of-Life Assessment
Ancillary studies
Other interventions: Questionnaire Administration
Ancillary studies
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Average Left-Ventricular Wall Thickness-Dimension Ratio Z-score (LVWT/Dz)
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Assessment method [1]
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Z-score of the ratio of left ventricular (LV) posterior wall dimension of systole to internal LV dimension in diastole, calculated for each subject by subtracting the reference healthy population mean, then dividing by the standard deviation. The Z-score indicates the number of standard deviations away from the mean of the reference population. Negative Z- score indicates worse outcome. The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [1]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [1]
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Average Left Ventricular End-systolic Wall Stress
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Assessment method [1]
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Echocardiographic measure of left ventricular (LV) afterload based on LV pressure (P), volume (V), and wall thickness (T), calculated by the formula (P x V)/T, which equals the number referred to below in the Measure Type. The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [1]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [2]
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Average Left Ventricular End-systolic Dimension
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Assessment method [2]
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Thickness of cardiac muscle (in cm) of the left ventricle at the end of systole. The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [2]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [3]
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Average Left Ventricular End-systolic Volume
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Assessment method [3]
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The amount of blood (in ml) in the heart's left ventricle just after the heart contracts. The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [3]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [4]
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Average Left Ventricular End-diastolic Dimension
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Assessment method [4]
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Thickness of cardiac muscle (in cm) of the left ventricle at the end of diastole. The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [4]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [5]
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Average Left Ventricular End-diastolic Volume
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Assessment method [5]
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The amount of blood (in ml) in the heart's left ventricle just before the heart contracts. The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [5]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [6]
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Average Left Ventricular Mass
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Assessment method [6]
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The weight of the left ventricle adjusted for body surface area (in g/m2). The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [6]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [7]
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Average Fractional Shortening
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Assessment method [7]
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A measure to assess preload and afterload (in %). The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [7]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [8]
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Average Ejection Fraction
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Assessment method [8]
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The percentage of blood leaving the heart at the end of diastole. The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [8]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [9]
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Average Peak Early Atrial Divided by Peak Late Atrial Velocities
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Assessment method [9]
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Ratio of peak velocity blood flow from left ventricular relaxation in early diastole (E wave) to peak velocity flow in late diastole caused by atrial contraction (A wave). "Number" shown for Unit of Measure refers to this ratio. Normal: >1. Impaired: <1. The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [9]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [10]
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Average N-terminal Pro B-type Natriuretic Peptide
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Assessment method [10]
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B-type natriuretic peptide- a biomarker for heart failure (in pg/ml). The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [10]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [11]
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Average Cardiac N-terminal Pro B-type Natriuretic Peptide
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Assessment method [11]
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N-terminal pro b-type natriuretic peptide- a biomarker for heart failure (in pg/ml). The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [11]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [12]
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Average Cardiac Troponin I
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Assessment method [12]
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Troponin I is a biomarker for myocardial cell injury (in ng/ml). The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [12]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [13]
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Average Galectin-3
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Assessment method [13]
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A protein produced by activated macrophages, and a member of a family of ß-galactoside-binding lectings and promotes cardiac fibroblast proliferation and collagen synthesis following myocadial injury (in ng/ml). The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [13]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [14]
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Proportion of Patients With Reportable Adverse Events as Described in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE).
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Assessment method [14]
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Patients with toxicities reported via CTEP-AERS and all Grade = 2 adverse events (AEs) that can be attributed probably or definitely to the study drug are considered to have AEs. The proportion of patients with AEs are reported by arm with corresponding 95% confidence intervals.
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Timepoint [14]
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From baseline to month 24 since baseline
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Secondary outcome [15]
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Average Bilirubin
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Assessment method [15]
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A liver function measurement (in mg/dL). The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [15]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [16]
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Average Aspartate Aminotransferase
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Assessment method [16]
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A liver function measurement (in U/L). Normal range is 14-20 for men, 10-36 for women. The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [16]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [17]
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Average Alanine Aminotransferase
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Assessment method [17]
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A liver function measurement (in U/L). Normal range is 8-48 IU/L. The mean is reported by arm at each timepoint with corresponding standard errors.
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Timepoint [17]
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Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
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Secondary outcome [18]
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Proportion of Participants With Average Adherence > 90%
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Assessment method [18]
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The number of pills taken out of the total prescribed in a 3-month period, averaged across all study time points. The proportion of participants with average adherence rate >90% is computed by arm and corresponding 95% confidence intervals are reported.
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Timepoint [18]
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Average adherence across 6 months, 12 months, 18 months, 24 months after treatment initiation are calculated.
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Secondary outcome [19]
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Proportion of Patients Who Responded "Moderately", "Quite a Bit", or "Extremely" to the Question of How Bothersome the Listed Symptom Was at Any Post-day 0 Assessment Time Point.
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Assessment method [19]
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In a questionnaire, patients responded Yes/No to certain symptoms. If answered Yes, they selected "slightly", "moderately", "quite a bit", or "extremely" regarding how bothersome the symptom was. The proportion of participants responding with any of these three categories was calculated by arm, and corresponding 95% confidence intervals are reported.
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Timepoint [19]
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Responses at days 14 to 730 were combined
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Eligibility
Key inclusion criteria
- Males and females must weigh >= 40 Kg
- 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
- Note: Institutional records (e.g., clinic note, treatment summary, chemotherapy
roadmap) can be used to document lifetime receipt of anthracycline dose
- Patient must have completed cancer treatment >= 2 years prior to study enrollment
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Receiving treatment for cardiomyopathy or heart failure
- Ejection fraction of < 50% (by radionuclide angiogram or echocardiogram) or shortening
fraction of < 25% (by echocardiogram)
- Note: for instances where both are reported, and one is below the threshold, the
site will have the option to re-measure it centrally at the core lab
- Uncorrected primary obstructive or severe regurgitative valvular disease:
- Nondilated (restrictive); or
- Hypertrophic cardiomyopathy; or
- Significant systemic ventricular outflow obstruction
- Sustained or symptomatic ventricular dysrhythmias uncontrolled with drug therapy or
implantable device
- Significant conduction defects (i.e. second or third degree atrio-ventricular block or
sick sinus syndrome)
- Bradycardia: heart rate < 50 beats per minute (BPM)
- Use of an investigational drug or beta adrenergic blockers, including metoprolol,
sotalol, within 30 days of enrollment
- History of drug sensitivity or allergic reaction to alpha or beta-blockers
- Low resting systolic blood pressure: < 90 mmHg
- Use of any other blood pressure lowering medication for treatment of hypertension
within 30 days of enrollment except calcium channel blockers and diuretics
- History or current clinical evidence of moderate-to-severe obstructive pulmonary
disease or reactive airway diseases (i.e. asthma) requiring therapy
- Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times
upper limit of institutional normal
- Gastrointestinal, or biliary disorders that could impair absorption, metabolism, or
excretion of orally administered medications
- 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%)
- Anemia (hematocrit < 28%)
- Currently using select CYP2D6 inhibitor or inducer medications
- Inability to swallow pills
- Female patients who are pregnant are not eligible; women of childbearing potential
require a negative pregnancy test prior to starting study drug
- Lactating females are not eligible unless they have agreed to not breastfeed their
infants
- Sexually active female patients of reproductive potential are not eligible unless they
agree to use an effective contraceptive method during study and for 2 months after
stopping the study drug; abstinence is an acceptable method of birth control
- All patients and/or their parents or legal guardians must sign a written informed
consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/04/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
196
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Princess Margaret Hospital for Children - Perth
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Recruitment hospital [2]
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Perth Children's Hospital - Perth
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Recruitment postcode(s) [1]
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6008 - Perth
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Recruitment postcode(s) [2]
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6009 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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Arizona
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Country [3]
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United States of America
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State/province [3]
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Arkansas
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Country [4]
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United States of America
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State/province [4]
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California
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Country [5]
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United States of America
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State/province [5]
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Colorado
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Country [6]
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United States of America
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State/province [6]
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Connecticut
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Country [7]
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United States of America
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State/province [7]
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Delaware
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Country [8]
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United States of America
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State/province [8]
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District of Columbia
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Country [9]
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United States of America
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State/province [9]
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Florida
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Country [10]
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United States of America
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State/province [10]
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Georgia
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United States of America
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State/province [11]
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Hawaii
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Country [12]
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United States of America
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State/province [12]
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Illinois
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United States of America
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State/province [13]
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Indiana
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United States of America
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State/province [14]
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Iowa
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Country [15]
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United States of America
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State/province [15]
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Kentucky
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Country [16]
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United States of America
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State/province [16]
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Louisiana
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Country [17]
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United States of America
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State/province [17]
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Maryland
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Country [18]
0
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United States of America
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State/province [18]
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Michigan
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United States of America
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State/province [19]
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Minnesota
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Mississippi
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United States of America
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Missouri
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United States of America
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Nebraska
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Country [23]
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State/province [23]
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Nevada
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State/province [24]
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New Jersey
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New York
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North Carolina
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Ohio
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State/province [28]
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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Washington
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Canada
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State/province [36]
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Nova Scotia
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Country [37]
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New Zealand
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State/province [37]
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Auckland
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Country [38]
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New Zealand
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State/province [38]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This phase IIb trial studies how well low-dose carvedilol works in preventing heart failure
in cancer survivors exposed to high dose anthracyclines for management of childhood cancer.
Patients who received high-dose anthracycline chemotherapy are at a much greater risk for
developing heart failure compared to survivors who didn't get any anthracycline chemotherapy.
Heart failure happens when the heart muscle has been weakened and can't pump blood as well as
it should. Carvedilol may help lower the risk of cardiovascular complications.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02717507
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Saro H Armenian
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Address
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Children's Oncology Group
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02717507
Download to PDF