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Completed

NCT Number: NCT02015312

A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)

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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Key information

Conditions

Light Chain (AL) Amyloidosis Amyloidosis Cardiac Involvement Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital of Heidelberg; Medical Department V

Heidelberg, Baden-Wurttemberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy proven systemic AL amyloidosis.
  • Cardiac involvement with septum thickness more than 12 mm (without other causes as published by Gertz et al., hypertension or other potential causes of left ventricular hypertrophy)
  • Previously treated with chemotherapy, induced at least a very good partial remission of the underlying monoclonal plasma cell or B cell disorder.
  • GPT and GOT less than 3-times ULN.
  • Life expectancy more than 12 month.
  • Ability of subject to understand character and individual consequences of the clinical trail.
  • Written informed consent.
  • For women with childbearing potential and men, adequate contraception.

Exclusion criteria

  • Age less than 18 years.
  • Concomitant multiple myeloma stage 2 and 3 (Salmon and Durie)
  • Concurrent chemotherapy necessary
  • Time to last chemotherapy more than 6 months.
  • Chronic liver disease, Bilirubin over 1,5 mg/dl
  • Not able to visit Amyloidosis Clinic in Heidelberg every 3 months.
  • History of hypersensitivity to the investigational product or to any substance with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
  • Participation in other clinical trials or observation period of competing trials, respectively.
  • Pregnant or nursing women.

Treatment and study plan

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

Other names: Epigallocatechin gallate, EGCG, Epigallocatechin 3-gallate, Tea catechin, Epigallocatechin-3-gallate

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

Other names: Mannitol 99.5% + highly dispersed silicon dioxide 0.5%

Primary outcomes

  1. compare the 12 month change in left ventricular mass

    Time frame: 12 month

    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.

Secondary outcomes

  1. Change in Quality of Life

    Time frame: baseline, 12 month

    Quality of Life, evaluated with EORTC-QLQ-C30

  2. safety of EGCG

    Time frame: 12 month

    Number of adverse events according to CTC criteria (Version 4.0)

  3. change in cardiac biomarkers

    Time frame: Baseline, 12 Month

    cardiac troponin T (hsTNT), NTproBNP

  4. improvement of hematological remission

    Time frame: Baseline, 12 Month

    Hematological Response according to Palladini et al 2012

  5. Organ response in affected organs other than heart

    Time frame: Baseline, 12 Month

    Organ response according to Gertz et al 2005

  6. Overall Survival

    Time frame: 12 Month

Sponsors and collaborators

Lead sponsor

Florian Michel

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

A Randomised Trial for the Treatment of Cardiac AMyloid Light-chain Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)

Acronym: TAME-AL

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2013
Registry last updated
Oct 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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