Early Detection of Broken Hearts in Cancer Patients
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | June 2013 |
| End Date: | September 2015 |
Early Detection of Broken Hearts in Cancer Patients: Bevacizumab, Sunitinib and Heart Failure
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.
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.
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.
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.
Inclusion Criteria:
1. Patients with advanced cancer
2. Treatment plan includes BVZ ,Sunitinib, or Pazopanib
3. Ages 18 - 90 years old -
Exclusion Criteria: Left Ventricular EF < 50%
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