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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Florian Michel

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Quality of Life [ Time Frame: baseline, 12 month ]
    Quality of Life, evaluated with EORTC-QLQ-C30
  • safety of EGCG [ Time Frame: 12 month ]
    Number of adverse events according to CTC criteria (Version 4.0)
  • change in cardiac biomarkers [ Time Frame: Baseline, 12 Month ]
    cardiac troponin T (hsTNT), NTproBNP
  • improvement of hematological remission [ Time Frame: Baseline, 12 Month ]
    Hematological Response according to Palladini et al 2012
  • Organ response in affected organs other than heart [ Time Frame: Baseline, 12 Month ]
    Organ response according to Gertz et al 2005
  • Overall Survival [ Time Frame: 12 Month ]


Original Secondary Outcome: Same as current

Information By: University Hospital Heidelberg

Dates:
Date Received: November 18, 2013
Date Started: April 2013
Date Completion: May 2018
Last Updated: December 9, 2016
Last Verified: December 2016