Epigallocatechingallate (EGCG) in Cardiac AL Amyloidosis (EpiCardiAL)
This study is currently recruiting participants.
Verified January 2012 by IRCCS Policlinico S. Matteo
Sponsor:
IRCCS Policlinico S. Matteo
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Amyloidosis of Light Chain Type |
Drug: Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhithmias) Drug: Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhythmias) plus EGCG |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Further study details as provided by IRCCS Policlinico S. Matteo:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 86 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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).
|
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.
|
|
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)
|
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. |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511263
Contacts
| Contact: Giampaolo Merlini, Prof. | +39(0)382502994 | gmerlini@unipv.it |
| Contact: Giovanni Palladini, Dr. | +39(0)382502994 | g.palladini@smatteo.pv.it |
Locations
| Italy | |
| Centro per lo Studio e la Cura delle Amiloidosi Sistemiche - Fondazione IRCCS Policlinico S.Matteo | Recruiting |
| Pavia, Italy, 27100 | |
| Contact: Giovanni Palladini, Dr. +39(0)382502994 g.palladini@smatteo.pv.it | |
| Contact: Leda Roggeri, Dr. +39(0)382502994 leda78@gmail.com | |
| Principal Investigator: Giampaolo Merlini, Prof. | |
| Sub-Investigator: Giovanni Palladini, Dr. | |
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
More Information
Additional Information:
Publications:
| Responsible Party: | Giampaolo Merlini, Director, Amyloidosis Research and Treatment Center, IRCCS Policlinico S. Matteo |
| ClinicalTrials.gov Identifier: | NCT01511263 History of Changes |
| Other Study ID Numbers: | AC-006-IT |
| Study First Received: | January 10, 2012 |
| Last Updated: | January 19, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by IRCCS Policlinico S. Matteo:
|
Epigallocatechin gallate AL amyloidosis |
Additional relevant MeSH terms:
|
Amyloidosis Proteostasis Deficiencies Metabolic Diseases Amiodarone Anti-Arrhythmia Agents Diuretics Epigallocatechin gallate Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Vasodilator Agents Natriuretic Agents Physiological Effects of Drugs Antioxidants Protective Agents Antimutagenic Agents Anticarcinogenic Agents Antineoplastic Agents Neuroprotective Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013