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:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT01531751
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of AL amyloidosis.
* Age ≥ 18 years.
* Evidence of a monoclonal light chain in serum and/or urine by positive immunofixation and abnormal FLC κ/λ ratio.
* Evidence of cardiac involvement at echocardiography (mean left ventricular wall thickness \> 12 mm in the absence of other causes).
* Cardiac stage III (both NT-proBNP \> 332 ng/L and cTnI \> 100 ng/L).
* Estimated GFR \< 15 mL/min per 1.73 m2 or requiring dialysis.
* NYHA class III or IV.
* Initiation of chemotherapy for AL amyloidosis scheduled between day 3 and day 8 after first HCO-HD session.
Exclusion Criteria:
* Non-AL (e.g. familial, senile) amyloidosis.
* Concomitant non-amyloid related clinically significant cardiac diseases.
* Involved (amyloidogenic) FLC \< 100 mg/L.
* Inability to undergo chemotherapy for AL amyloidosis.
* Uncontrolled infection.
* Inability to give informed consent.
* Previous or ongoing psychiatric illness (excluding reactive depression).
* Pregnant or nursing women.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01531751
Study Brief:
Protocol Section:
NCT01531751