Early Detection of Broken Hearts in Cancer Patients
Condition: Cardiotoxicity
MeSH terms: Cardiotoxicity
Study type: Observational

Summary: 
      The early detection of BVZ or Sunitinib mediated cardiotoxicity using cardiac biomarkers and
      novel Transthoracic Echocardiogram (TTE) techniques may allow one to adjust treatment and/or
      administer prophylactic cardioprotective agents, prior to the development of irreversible
      cardiac dysfunction. We hypothesize that cardiac biomarkers, TVI/strain-derived indices will
      be able to accurately detect subtle cardiac injury at a time when conventional Left
      Ventricular Ejection Fraction (LVEF) remains normal in BVZ or Sunitinib mediated
      cardiotoxicity. Additionally, we hypothesize that Endothelial Function Test (EndoPAT) testing
      can detect early BVZ or Sunitinib mediated endothelial dysfunction.
    

Detailed description: 
      A total of 100 individuals (50 receiving BVZ and 50 receiving Sunitinib) will be
      prospectively enrolled . (80 at Mayo Clinic [80 receiving BVZ, Sunitinib ,or Pazopanib] and
      20 at St. Boniface General Hospital (SBGH)). Patients receiving either BVZ 5mg/kg iv
      ,Sunitinib 50 mg po daily, or Pazopanib for advanced Metastatic carcinoma will be screened
      for potential eligibility in the study. For metastatic renal cancer treatments, Sunitinib
      doses are (oral) 50 mg once a day for 4 weeks followed by a two week off period. The six week
      cycle is then repeated. In case of toxicities observed with the dose, a 25% reduction in the
      daily dose during the "on" period is performed (37.5 mg). Patients will be studied at 7 time
      points: i) Baseline; ii) Day 1; iii) Day 5; iv) 4-6 weeks ; v) 3 months; vi) 6 months after
      the initiation of both drugs (BVZ and Sunitinib) ; and vii) 12 months after the initiation of
      BVZ drug only (Figure 1). Three visits (baseline, 4-6 weeks , and 3 months) are considered
      part of standard clinical care, and four visits are for research. At each visit, in addition
      to standard of care provided by the Oncologist, blood will be drawn to measure high
      sensitivity troponin-T (hsTnT) and Natriuretic-proBNP. The patients will also undergo a TTE
      with tissue velocity imaging (TVI), strain and left ventricular opacification (LVO) and
      myocardial perfusion at each time point. EndoPAT test will also be performed at baseline, and
      3 months. The baseline, 4-6 weeks, and 3 month visits will be part of your standard clinical
      care and followup.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 100 individuals with advanced metastatic renal cell carcinoma or colorectal
        cancer (50 receiving BVZ and 50 receiving Sunitinib) will be prospectively enrolled . (80
        at Mayo Clinic( Any subject presenting who will be treated for cancer recieving Pazopanib,
        Sutent, or Bevacizumab] and 20 at St. Boniface General Hospital (SBGH)).
      
Biospecimen description: 
      Blood will be drawn to measure blood biomarkers to determine your heart biomarker [High
      sensitivity TnT and NT-proBNP] as an indicator of early heart failure.
    
Keywords: Chemotherapy; Cardiotoxicity