ISRCTN68399350
Completed
Phase 2
A randomised trial for the Treatment of cardiac AMyloid light-chain amyloidosis with the green tea compound Epigallocatechin-3-gALlate (TAME-AL)
Ruprecht-Karls-University of Heidelberg (Germany)0 sites38 target enrollmentOctober 5, 2012
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Amyloid light-chain amyloidosis
- Sponsor
- Ruprecht-Karls-University of Heidelberg (Germany)
- Enrollment
- 38
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •1\. Age \< 18 years
- •2\. Concomitant multiple myeloma stage II and III (Salmon and Durie)
- •3\. Concurrent chemotherapy necessary
- •4\. Time to last chemotherapy \> 6 months
- •5\. Chronic liver disease
- •6\. Bilirubin \> 1,5 mg/dl
- •7\. Not able to visit Amyloidosis Clinic in Heidelberg every 3 months
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
A randomised clinical trial of cardiopulmonary resuscitation (CPR) prior to defibrillation for the treatment of out-of-hospital ventricular fibrillatioISRCTN87778564Western Australian Prehospital Care Research Unit (Australia)256
Completed
Not Applicable
Randomized clinical trial for an extended cardiac rehabilitation program using telemonitoringcardiovascular diseaseheart disease10028593NL-OMON41024niversitair Medisch Centrum Sint Radboud120
Recruiting
Phase 3
Effect of cardiac rehabilitation in patients undergone myocardial infarction and percutaneous coronary interventioHealth Condition 1: I21- Acute myocardial infarctionCTRI/2019/06/019948Dr JS Thakur
Recruiting
Phase 4
Clinical study on the treatment of myocardial remodeling after acute myocardial infarction by integrated traditional Chinese and western medicineITMCTR2100005045Qilu Hospital of Shandong University
Not yet recruiting
Phase 2
A cohort study on the treatment of coronary heart disease with the method of promoting qi and blood circulation (retrospective)Coronary heart diseaseITMCTR2023000063Xiyuan Hospital, China Academy of Chinese Medical Sciences