Status:
TERMINATED
Epigallocatechingallate (EGCG) in Cardiac AL Amyloidosis
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Primary Amyloidosis of Light Chain Type
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In a proportion of patients with AL amyloidosis there is no improvement of cardiac function despite hematologic response to treatment. The aim of the study is to assess whether treatment with EGCG inc...
Detailed Description
This will be a phase II open-label randomized trial. Patients with AL amyloidosis and cardiac involvement who have achieved at least partial hematologic response after chemotherapy will be randomized ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT01511263
Start Date
January 1 2012
End Date
July 1 2016
Last Update
March 21 2018
Active Locations (1)
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1
Centro per lo Studio e la Cura delle Amiloidosi Sistemiche - Fondazione IRCCS Policlinico S.Matteo
Pavia, Italy, 27100