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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT05880160
Eligibility Criteria:
Inclusion Criteria:
1. Adult participants (\>18 years)
2. A prior diagnosis of human epidermal growth factor receptor 2 (HER2)- targeted therapy related cardiac dysfunction, who currently receive standard heart failure/cardioprotective medications (any combination of angiotensin-converting enzyme \[ACE\] inhibitors, angiotensin receptor blockers \[ARBs\] and/or beta-blockers).
3. Cardiac function has 'recovered'. 'Recovery' is defined as absence of heart failure symptoms with left ventricular ejection fraction (LVEF) improved to 50% or greater and N-terminal pro B-type natriuretic peptide (NTproBNP) \<125ng/L, for greater than 6 months.
Exclusion Criteria:
1. Advanced/ metastatic HER2 positive breast cancer requiring ongoing HER2 therapies or with life expectancy \<12months.
2. Patients classed as high/very high cardiovascular risk according to the International Cardio-Oncology Society (ICOS) risk stratification
3. Patients with LVEF \<50% prior to HER2-therapy initiation or on completion of anthracycline treatment
4. Patients with ongoing indications for the cardioprotective medication - ACE inhibitors, ARBs and/or beta-blockers
5. Patients with absolute contraindications to cardiovascular magnetic resonance scans (CMR).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05880160
Study Brief:
Protocol Section:
NCT05880160