TerminatedPhase 2

Epigallocatechingallate (EGCG) in Cardiac AL Amyloidosis

Italy86 participantsStarted 2012-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Cardiac response

Timeframe: 6 months

Trial details

NCT IDNCT01511263

SponsorFondazione IRCCS Policlinico San Matteo di Pavia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-07

View on ClinicalTrials.gov More Primary Amyloidosis of Light Chain Type trials