Treatment of cardiac amyloid light-chain amyloidosis with the green tea compound epigallocatechin-3-galiate

A randomised trial for the Treatment of cardiac AMyloid light-chain amyloidosis with the green tea compound Epigallocatechin-3-gALlate (TAME-AL)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68399350

Enrollment

Registered

2012-10-05

Start date

2012-12-01

Completion date

Unknown

Last updated

2016-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloid light-chain amyloidosis Nutritional, Metabolic, Endocrine Amyloidosis

Interventions

EGCG capsules 400-1200 mg in increasing dosages or placebo for 1 year

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Biopsy proven systemic AL amyloidosis 2. Cardiac involvement with septum thickness >12 mm (without other causes as published by Gertz et al) 3. Hypertension or other potential causes of left ventricular hypertrophy 4. Previously treated with chemotherapy 5. Induced at least a very good partial remission of the underlying monoclonal plasma cell or B cell disorder

Exclusion criteria

Exclusion criteria: 1. Age 6 months 5. Chronic liver disease 6. Bilirubin > 1,5 mg/dl 7. Not able to visit Amyloidosis Clinic in Heidelberg every 3 months

Design outcomes

Primary

Measure	Time frame
Left ventricular mass, measured by cardiac MRI	—

Secondary

Measure	Time frame
1. Quality of life, measured using the EORTC-QLQ-C30 2. Left ventricle (LV) end diastolic and end systolic volumes with resulting ejection fraction, measured by cardiac MRI 3. Cardiac function parameters (calculated left ventricular mass, Tissue DI, TAPSE, MAPSE) 4. Cardiac biomarkers (cardiac troponin T hsTNT, NTproBNP) 5. 6-minute walk distance 6. Organ response in other affected organs, Gertz et al., 2005; standard criteria 7. Improvement of hematological remission 8. Overall survival 9. Correlation of epigallocatechin gallate (EGCG) serum levels with organ response 10. Number of adverse events according to Common Toxicity Criteria (CTC) version 4.0 Measured 12 months after the start of treatment	—

Measure

Time frame

1. Quality of life, measured using the EORTC-QLQ-C30 2. Left ventricle (LV) end diastolic and end systolic volumes with resulting ejection fraction, measured by cardiac MRI 3. Cardiac function parameters (calculated left ventricular mass, Tissue DI, TAPSE, MAPSE) 4. Cardiac biomarkers (cardiac troponin T hsTNT, NTproBNP) 5. 6-minute walk distance 6. Organ response in other affected organs, Gertz et al., 2005; standard criteria 7. Improvement of hematological remission 8. Overall survival 9. Correlation of epigallocatechin gallate (EGCG) serum levels with organ response 10. Number of adverse events according to Common Toxicity Criteria (CTC) version 4.0 Measured 12 months after the start of treatment

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026