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Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Congestive Heart Failure (PREVENT-CHF): A Phase IIB Randomized Placebo-Controlled Trial
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Congestive Heart Failure (PREVENT-CHF): A Phase IIB Randomized Placebo-Controlled Trial
 
Region Sponsors
California - Southern
City of Hope Medical Center
 
Acronym KP IRB No.
11062
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
Cancer Survivors
 
Purpose
This randomized phase II trial studies the side effects and how well low-dose carvedilol works in preventing congestive heart failure (CHF) in younger cancer survivors exposed to high dose anthracyclines for management of childhood cancer. Carvedilol may help lower the risk of cardiovascular complications
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Cancer diagnosis prior to 22 years of age, irrespective of current age
  • Lifetime cumulative anthracycline dose >= 300 mg/m^2 without the protection of dexrazoxane (Zinecard) therapy
  • Time from completion of cancer treatment to study entry >= 2 years
 
Exclusion Criteria
  • Receiving treatment for cardiomyopathy or congestive heart failure
  • Resting ejection fraction < 50% or fractional shortening < 25%
  • Uncorrected primary obstructive or severe regurgitative valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathy, or significant systemic ventricular outflow obstruction
  • Low resting systolic blood pressure: < 90 mm hemoglobin (Hg)
  • Bradycardia: heart rate < 50 beats per minute (BPM)
  • 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)
  • History or current clinical evidence of moderate -to-severe obstructive pulmonary disease or reactive airway diseases (i.e.: asthma) requiring therapy
  • Significant hepatic (serum aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] > 3 time upper limit of normal 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, or insulin dependent diabetes mellitus
  • Females of child bearing potential who are pregnant, lactating, or sexually active and not taking adequate contraceptive precautions (i.e. intrauterine device [IUD] or oral contraceptives for 3 months prior to entry into the study)
  • History of drug sensitivity or allergic reaction to alpha- or beta-blockers
  • Anemia (hematocrit < 28%)

 
Keywords and/or Specific Medical Conditions
  • Adrenergic Agents
  • Molecular Mechanisms of Pharmacological Action
  • Adrenergic alpha-1 Receptor Antagonists
  • Neurotransmitter Agents
  • Adrenergic alpha-Antagonists
  • Pathological Conditions, Anatomical
  • Adrenergic Antagonists
  • Physiological Effects of Drugs
  • Adrenergic beta-Antagonists
  • Vasodilator Agents
  • Antihypertensive Agents
  • Ventricular Remodeling
  • Cardiovascular Diseases
  • Heart Failure
  • Carvedilol
  • Oncology (Pediatrics)
  • Heart Diseases
 
KP Clinical Facility
  • Los Angeles (Sunset)
 
Clinical Area
  • Oncology (Pediatrics)


Principal Investigator:
Robert Cooper, MD
Contact Information:
- Kaiser Permanente Clinical Trials
-844-294-4114
-clinical.trials@kp.org
-Southern California


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