Epigallocatechingallate (EGCG) in Cardiac AL Amyloidosis (EpiCardiAL)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by IRCCS Policlinico S. Matteo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Giampaolo Merlini, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT01511263
First received: January 10, 2012
Last updated: January 19, 2012
Last verified: January 2012

January 10, 2012
January 19, 2012
January 2012
January 2013   (final data collection date for primary outcome measure)
Cardiac response [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
The primary objective is to assess whether treatment with EGCG increases the rate of cardiac response following chemotherapy in patients with AL amyloidosis. The primary endpoint is cardiac response at 6 months.
Same as current
Complete list of historical versions of study NCT01511263 on ClinicalTrials.gov Archive Site
  • Rate of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The secondary objectives are to assess the safety of EGCG in cardiac AL amyloidosis, to determine whether EGCG can prevent or delay cardiac progression and to compare survival of patients receiving EGCG compared to subjects receiving SST.
  • Rate of cardiac progression [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The secondary objectives are to assess the safety of EGCG in cardiac AL amyloidosis, to determine whether EGCG can prevent or delay cardiac progression and to compare survival of patients receiving EGCG compared to subjects receiving SST.
  • Time to cardiac progression [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The secondary objectives are to assess the safety of EGCG in cardiac AL amyloidosis, to determine whether EGCG can prevent or delay cardiac progression and to compare survival of patients receiving EGCG compared to subjects receiving SST.
  • Rate of cardiac events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The secondary objectives are to assess the safety of EGCG in cardiac AL amyloidosis, to determine whether EGCG can prevent or delay cardiac progression and to compare survival of patients receiving EGCG compared to subjects receiving SST.
  • Time to cardiac events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The secondary objectives are to assess the safety of EGCG in cardiac AL amyloidosis, to determine whether EGCG can prevent or delay cardiac progression and to compare survival of patients receiving EGCG compared to subjects receiving SST.
  • Survival [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The secondary objectives are to assess the safety of EGCG in cardiac AL amyloidosis, to determine whether EGCG can prevent or delay cardiac progression and to compare survival of patients receiving EGCG compared to subjects receiving SST.
Same as current
Not Provided
Not Provided
 
Epigallocatechingallate (EGCG) in Cardiac AL Amyloidosis
A Phase II Open-label Randomized Study of Dietary Supplement With Epigallocatechin Gallate (EGCG) to Improve Cardiac Dysfunction in Patients With AL Amyloidosis Who do Not Require Chemotherapy (EpiCardiAL)

In a proportion of patients with AL amyloidosis there is no improvement of cardiac function despite hematologic response to treatment. The aim of the study is to assess whether treatment with EGCG increases the rate of cardiac response in patients with AL amyloidosis who completed chemotherapy.

This will be a phase II open-label randomized trial. Patients with AL amyloidosis and cardiac involvement who have achieved at least partial hematologic response after chemotherapy will be randomized to receive standard supportive therapy (SST) or SST plus Epigallocatechin gallate (EGCG). After giving written informed consent, the patients will be evaluated for eligibility. Briefly, the subjects with a biopsy-proven diagnosis of AL amyloidosis who achieved at least partial response after chemotherapy, who are not planned to receive further chemotherapy and who have significant cardiac dysfunction will be considered eligible. The patients will be stratified according to the quality of hematologic response and to the severity of cardiac involvement. Following stratification, the patients will be randomized to receive SST or SST plus EGCG. The study comprises 3 periods: screening (including stratification and randomization), treatment (with evaluations of response every 2 months) followed by the end-of-treatment evaluation and follow-up. Therapy will continue for up to 1 year. After treatment patients will be followed for 3 years.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Amyloidosis of Light Chain Type
  • Drug: Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhithmias)
    Antiarrhythmic drugs (i.e. amiodarone), angiotensins which transform inhibitor enzymes, and/or beta-blockers if tolerated.
  • Drug: Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhythmias) plus EGCG

    Antiarrhythmic drugs (i.e. amiodarone), angiotensins which transform inhibitor enzymes, and/or beta-blockers if tolerated.

    EGCG, 675 mg/day, oral, for one year.

  • Active Comparator: Arm A
    The patients will be divided into 4 strata according to cardiac dysfunction and to the quality of hematologic response. After stratification the patients will be randomized (1:1) within each stratum to receive Standard Therapy alone (Arm A) or Standard Therapy plus Investigational Drug (Arm B).
    Intervention: Drug: Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhithmias)
  • Experimental: Arm B
    The patients will be divided into 4 strata according to cardiac dysfunction and to the quality of hematologic response. After stratification the patients will be randomized (1:1) within each stratum to receive Standard Therapy alone (Arm A) or Standard Therapy plus Investigational Drug (Arm B)
    Intervention: Drug: Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhythmias) plus EGCG

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
86
December 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of AL amyloidosis.
  • Age ≥18 years.
  • The patients must have been treated for AL amyloidosis attaining hematologic response.
  • Evidence of cardiac involvement at echocardiography (mean left ventricular wall thickness >12 mm in the absence of other causes).
  • NT-proBNP ≥650 ng/L

Exclusion Criteria:

  • Non-AL (e.g. familial, senile) amyloidosis.
  • Concomitant non-amyloid related clinically significant cardiac diseases.
  • Need of further chemotherapy for AL amyloidosis.
  • Estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73 m2.
  • Uncontrolled infection.
  • Inability to give informed consent.
  • Previous or ongoing psychiatric illness (excluding reactive depression).
  • Pregnant or nursing women.
Both
18 Years and older
No
Contact: Giampaolo Merlini, Prof. +39(0)382502994 gmerlini@unipv.it
Contact: Giovanni Palladini, Dr. +39(0)382502994 g.palladini@smatteo.pv.it
Italy
 
NCT01511263
AC-006-IT
Yes
Giampaolo Merlini, IRCCS Policlinico S. Matteo
IRCCS Policlinico S. Matteo
Not Provided
Not Provided
IRCCS Policlinico S. Matteo
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP