- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02086695
Early Detection of Broken Hearts in Cancer Patients (ASPER)
January 27, 2016 updated by: Sharon Mulvagh, Mayo Clinic
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
43
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
- St. Boniface General Hospital
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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)).
Description
Inclusion Criteria:
- Patients with advanced cancer
- Treatment plan includes BVZ ,Sunitinib, or Pazopanib
- Ages 18 - 90 years old -
Exclusion Criteria: Left Ventricular EF < 50%
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cancer Group
All subjects with cancer who will be treated with anyone of the following chemotherapy drugs; Pazopanib, Sutent or Bevacizumab
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Number of participants with changes in Tissue velocity imaging (TVI), myocardial deformation indices (Strain, strain rate, twist and torsion), and diastolic function indices (Mitral Valve Pulsed Wave Doppler, Tissue Doppler Imaging, Left Atrial volumes)
Time Frame: Baseline to 2 years
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Baseline to 2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with changes in quantitative myocardial perfusion parameters including myocardial blood flow velocity and myocardial blood flow derived from contrast perfusion echocardiography
Time Frame: Baseline to 2 years
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Baseline to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (ACTUAL)
September 1, 2015
Study Completion (ACTUAL)
September 1, 2015
Study Registration Dates
First Submitted
October 16, 2013
First Submitted That Met QC Criteria
March 11, 2014
First Posted (ESTIMATE)
March 13, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
January 29, 2016
Last Update Submitted That Met QC Criteria
January 27, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-005362
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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