Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT01434134
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01434134
Study Brief:
Protocol Section:
NCT01434134