Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: Female

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 heart failure medications such as beta blockers and angiotensin receptor blockers can prevent cardiac dysfunction during early breast cancer therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Akershus
• Collaborators: AstraZeneca; Norwegian Cancer Society; University of Oslo
• Treatments: Candesartan; Candesartan cilexetil; Metoprolol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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