Status:
COMPLETED
Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy
Lead Sponsor:
University Hospital, Akershus
Collaborating Sponsors:
University of Oslo
Norwegian Cancer Society
Conditions:
Breast Cancer
Heart Failure
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
Women treated for breast cancer are at increased risk for cardiovascular disease, including heart failure. In this study, by using magnetic resonance imaging (MRI), the investigators want to assess if...
Detailed Description
Breast cancer is one of the most common malignancies in women. Recent progress in the detection and treatment of breast cancer has resulted in survival gains, but a consequence of therapeutic advances...
Eligibility Criteria
Inclusion
- Women aged 18-70 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Serum creatinine \< 140 μmol/L or estimated creatinine clearance \> 60 ml/min (using the modification of diet and renal disease (MDRD) formula)
- Systolic blood pressure \>= 110 mgHg and \< 170 mmHg
- LVEF \>= 50%
Exclusion
- Hypotension, defined as systolic blood pressure \< 110 mmHg
- Bradycardia, defined as heart rate \< 50 b.p.m.
- Prior anthracycline chemotherapy regimen
- Prior malignancy requiring chemotherapy or radiotherapy
- Symptomatic heart failure
- Systolic dysfunction (LVEF \< 50%)
- Clinically significant coronary artery disease, valvular heart disease, significant arrhythmias, or conduction delays.
- Uncontrolled arterial hypertension defined as systolic blood pressure \> 170 mm Hg
- Treatment with ACEI, ARB or beta-blocker within the last 4 weeks prior to study start
- Intolerance to ACEI, ARB or beta-blocker
- Uncontrolled concomitant serious illness
- Pregnancy or breastfeeding
- Active abuse of drugs or alcohol
- Suspected poor compliance
- Inability to tolerate the MRI scanning protocol
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01434134
Start Date
September 1 2011
End Date
September 1 2014
Last Update
October 22 2014
Active Locations (1)
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1
Akershus University Hospital
Lørenskog, Norway, 1478