Efficacy and safety of epigallocatechin-3-gallate (EGCG) in patients with cardiac amyloid light-chain (AL) amyloidosis. Evaluation of clinical efficacy of EGCG intake using a pretest posttest comparison of left ventricular amyloid mass (g/m2) measured by cardiac MRI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
Pharmaceutical formulation: capsules Dose: 400 mg/d for 3 months; 800 mg/d for 3 months, 1200 mg/d for 6 months Route of administration: p.o. Treatment duration: 12 months
Pharmaceutical formulation: capsules Dose: 400 mg/d for 3 months; 800 mg/d for 3 months, 1200 mg/d for 6 months Route of administration: p.o. Treatment duration: 12 months
University Hospital of Heidelberg; Medical Department V
Heidelberg, Baden-Wurttemberg, Germany
compare the 12 month change in left ventricular mass
The primary analysis to compare the 12 month change in left ventricular mass between the two treatment arms will be performed by a one-sided two-sample t test at a significance level of 0.025.
Time frame: 12 month
Change in Quality of Life
Quality of Life, evaluated with EORTC-QLQ-C30
Time frame: baseline, 12 month
safety of EGCG
Number of adverse events according to CTC criteria (Version 4.0)
Time frame: 12 month
change in cardiac biomarkers
cardiac troponin T (hsTNT), NTproBNP
Time frame: Baseline, 12 Month
improvement of hematological remission
Hematological Response according to Palladini et al 2012
Time frame: Baseline, 12 Month
Organ response in affected organs other than heart
Organ response according to Gertz et al 2005
Time frame: Baseline, 12 Month
Overall Survival
Time frame: 12 Month
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