Epigallocatechingallate (EGCG) in Cardiac AL Amyloidosis (EpiCardiAL)
Primary Amyloidosis of Light Chain Type
About this trial
This is an interventional treatment trial for Primary Amyloidosis of Light Chain Type focused on measuring Epigallocatechin gallate, AL amyloidosis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of AL amyloidosis.
- Age ≥18 years.
- The patients must have been treated for AL amyloidosis attaining hematologic response.
- Evidence of cardiac involvement at echocardiography (mean left ventricular wall thickness >12 mm in the absence of other causes).
- NT-proBNP ≥650 ng/L
Exclusion Criteria:
- Non-AL (e.g. familial, senile) amyloidosis.
- Concomitant non-amyloid related clinically significant cardiac diseases.
- Need of further chemotherapy for AL amyloidosis.
- Estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73 m2.
- Uncontrolled infection.
- Inability to give informed consent.
- Previous or ongoing psychiatric illness (excluding reactive depression).
- Pregnant or nursing women.
Sites / Locations
- Centro per lo Studio e la Cura delle Amiloidosi Sistemiche - Fondazione IRCCS Policlinico S.Matteo
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm A
Arm B
The patients will be divided into 4 strata according to cardiac dysfunction and to the quality of hematologic response. After stratification the patients will be randomized (1:1) within each stratum to receive Standard Therapy alone (Arm A) or Standard Therapy plus Investigational Drug (Arm B).
The patients will be divided into 4 strata according to cardiac dysfunction and to the quality of hematologic response. After stratification the patients will be randomized (1:1) within each stratum to receive Standard Therapy alone (Arm A) or Standard Therapy plus Investigational Drug (Arm B)