Epigallocatechingallate (EGCG) in Cardiac AL Amyloidosis

• Status: Terminated
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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 increases the rate of cardiac response in patients with AL amyloidosis who completed chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Policlinico S. Matteo
• Treatments: Amiodarone; Anti-Arrhythmia Agents; Diuretics; Epigallocatechin gallate

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.