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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004520-38 | EudraCT Number |
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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epigallocatechin-3-gallate (EGCG) | Experimental | EGCG 400 mg/d p.o. for 3 months; 800 mg/d p.o. for 3 months, 1200 mg/d p.o. for 6 months |
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| Placebo | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epigallocatechin-3-gallate (EGCG) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | Quality of Life, evaluated with EORTC-QLQ-C30 | baseline, 12 month |
| safety of EGCG | Number of adverse events according to CTC criteria (Version 4.0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Schönland, MD | University Hospital of Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Heidelberg; Medical Department V | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
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| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C045651 | epigallocatechin gallate |
| C420224 | epigallocatechin-3-(3''-O-methyl)gallate |
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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|
| Placebo | Drug | 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 |
|
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| 12 month |
| change in cardiac biomarkers | cardiac troponin T (hsTNT), NTproBNP | Baseline, 12 Month |
| improvement of hematological remission | Hematological Response according to Palladini et al 2012 | Baseline, 12 Month |
| Organ response in affected organs other than heart | Organ response according to Gertz et al 2005 | Baseline, 12 Month |
| Overall Survival | 12 Month |