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 ]
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