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OpenTrials
Completed

NCT Number: NCT02086695

Early Detection of Broken Hearts in Cancer Patients

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Boniface General Hospital, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with advanced cancer
  • Treatment plan includes BVZ ,Sunitinib, or Pazopanib
  • Ages 18 - 90 years old -

Exclusion criteria

Left Ventricular EF < 50%

-

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Lantheus Medical Imaging
  • St. Boniface Hospital
  • The Asper Foundation

Registry information

Official study title

Early Detection of Broken Hearts in Cancer Patients: Bevacizumab, Sunitinib and Heart Failure

Acronym: ASPER

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 13, 2014
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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