Early Detection of Broken Hearts in Cancer Patients

NCT02086695 | Completed

• 1 other identifier: 12-005362
• Study Type: observational
• Target: 43
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Cardiotoxicity

Keywords

Chemotherapy; Cardiotoxicity

Outcome Measures

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)

  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

  Baseline to 2 years

Study Arms (1)

Cancer Group

All subjects with cancer who will be treated with anyone of the following chemotherapy drugs; Pazopanib, Sutent or Bevacizumab

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)).

You may qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• The Asper Foundation: collaborator
• St. Boniface Hospital: collaborator
• Lantheus Medical Imaging: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant of Cardiology Noninvasive

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: March 13, 2014
• Study Start: June 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 29, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)