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Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy (ATTRibute-CM)

Primary Purpose

Amyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
acoramidis
Placebo Oral Tablet
Sponsored by
Eidos Therapeutics, a BridgeBio company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyloidosis focused on measuring Amyloidosis, ATTR-CM, Transthyretin, Amyloid, TTR

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have an established diagnosis of ATTR-CM with either wild-type TTR or variant TTR genotype
  • Have a history of heart failure evidenced by at least one prior hospitalization for heart failure or clinical evidence of heart failure without prior heart failure hospitalization manifested by signs or symptoms of volume overload or elevated intracardiac pressures or heart failure symptoms that required or require ongoing treatment with a diuretic.
  • New York Heart Association (NYHA) Class I-III symptoms due to ATTR cardiomyopathy.
  • On stable doses of cardiovascular medical therapy
  • Completed ≥150 m on the 6MWT on 2 tests that are within 15% of total distance walked prior to randomization
  • Biomarkers of myocardial wall stress, NT-proBNP level ≥300 pg/mL at screening
  • Have left ventricular wall (interventricular septum or left ventricular posterior wall) thickness ≥12 mm

Exclusion Criteria:

  • Had acute myocardial infarction, acute coronary syndrome or coronary revascularization, or experienced stroke or transient ischemic attack within 90 days prior to screening
  • Has hemodynamic instability
  • Likely to undergo heart transplantation within a year of screening
  • Confirmed diagnosis of primary (light chain) amyloidosis
  • Biomarkers of myocardial wall stress, NT-proBNP level ≥8500 pg/mL at screening
  • Measure of kidney function, eGFR by MDRD formula <15 mL/min/1.73 m2
  • Current treatment with marketed drug products and other investigational agents for the treatment of ATTR-CM
  • Current treatment with calcium channel blockers with conduction system effects (e.g. verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digitalis will only be allowed if required for management of atrial fibrillation with rapid ventricular response

Sites / Locations

  • Cedars-Sinai Medical Center
  • Pacific Heart Institute
  • University of Colorado Hospital - Anschutz Medical Campus
  • Yale School of Medicine
  • MedStar Washington Hospital Center
  • University of Miami - Sylvester Comprehensive Cancer Center
  • Piedmont Heart Institute Athens
  • Emory Heart and Vascular Center
  • Northwestern University
  • The University of Chicago Medical Center
  • NorthShore University Health System
  • Indiana University
  • MedStar Medical Group Cardiology at Franklin Square Medical Center
  • Boston University School of Medicine
  • Saint Elizabeth's Medical Center
  • Mayo Clinic
  • Saint Luke's Hospital - Kansas City
  • Washington University School of Medicine
  • Newark Beth Israel Medical Center
  • Montefiore Medical Center
  • North Shore University Hospital
  • New York University Langone Health
  • Mount Sinai Hospital
  • Columbia University Medical Center
  • Laurelton Heart Specialist
  • University of North Carolina - Chapel Hill
  • Duke University Health System
  • Cleveland Clinic
  • Oregon Health and Science University
  • Penn Presbyterian Medical Center
  • Allegheny General Hospital
  • University of Pittsburgh
  • The Medical University of South Carolina
  • Prisma Health - Greenville Memorial Hospital
  • University of Texas Southwestern Medical Center
  • University of Utah
  • Virginia Commonwealth University Medical Center
  • Carilion Clinic Roanoke Heart Institute
  • University of Washington School of Medicine
  • Providence Sacred Heart Medical Center
  • Royal Adelaide Hospital
  • Box Hill Hospital
  • Royal Hobart Hospital
  • Fiona Stanley Hospital
  • Saint Vincent's Hospital Sydney
  • Princess Alexandra Hospital
  • Ziekenhuis Oost-Limburg - Campus Sint-Jan
  • Jessa Ziekenhuis - Campus Virga Jesse
  • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
  • Onze-Lieve-Vrouw Ziekenhuis Aalst
  • Universitair Ziekenhuis Leuven
  • Hospital Cárdio Pulmonar
  • Santa Casa de Misericordia - Porto Alegre
  • CAPED - Centro Avançado de Pesquisa e Estudos para o Diagnóstico
  • INCOR
  • Instituto de Cardiologia do Rio Grande do Sul
  • University of Calgary
  • University of British Columbia
  • CancerCare Manitoba - St. Boniface
  • Halifax Infirmary
  • Toronto Heart Centre
  • University of Toronto
  • Centre Hospitalier de L'Universite de Montreal - Hôpital Notre-Dame
  • Hôpital du Sacré-Coeur de Montréal
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec
  • Hôpital régional de Rimouski
  • Montreal Heart Institute
  • St. Anne´s University Hospital
  • General University Hospital in Prague
  • Institute for Clinical and Experimental Medicine
  • Aarhus Universitetshospital
  • Alexandra General Hospital of Athens
  • Mater Misericordiae University Hospital
  • Saint Vincents University Hospital
  • Hadassah University Hospital Ein Kerem
  • The Chaim Sheba Medical Center
  • Ospedale San Donato
  • Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
  • Azienda Ospedaliero - Universitaria Careggi
  • Fondazione IRCCS Policlinico San Matteo
  • Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanità Pubblica
  • Ospedale degli Infermi
  • Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Maastricht Universitair Medisch Centrum
  • Universitair Medisch Centrum Groningen
  • Universitair Medisch Centrum Utrecht
  • Middlemore Hospital
  • Waikato Hospital
  • National Institute of Cardiology
  • Centro Hospitalar de Lisboa Norte EPE- Hospital Santa Maria
  • Centro Hospitalar do Porto
  • Clínica Universidad de Navarra
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Juan Ramón Jiménez
  • Hospital Juan Ramón Jiménez
  • Clinica Universidad de Navarra Madrid
  • Hospital Universitario Puerta de Hierro
  • Hospital Son Llàtzer
  • Hospital Clínico Universitario de Santiago de Compostela
  • Hospital Clínico Universitario de Valencia
  • Royal Free Hospital
  • Richmond Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

acoramidis HCl 800 mg

Placebo

Arm Description

Subjects will receive acoramidis HCl 800 mg twice daily. 6MWT primary outcome will be assessed at the end of 12 months. The hierarchical combination of All-Cause mortality, cumulative frequency of cardiovascular-related hospitalizations, change from baseline in NT-proBNP levels, and change from baseline in distance walked on the 6MWT will be assessed after 30 months of treatment.

Subjects will receive placebo to match twice daily. 6MWT primary outcome will be assessed at the end of 12 months. The hierarchical combination of All-Cause mortality, cumulative frequency of cardiovascular-related hospitalizations, change from baseline in NT-proBNP levels, and change from baseline in distance walked on the 6MWT will be assessed after 30 months of treatment.

Outcomes

Primary Outcome Measures

6-Minute Walk Test (6MWT) through Month 12
Change from baseline to Month 12 of treatment in the total distance walked in 6 minutes
A hierarchical combination of all-cause mortality, cumulative frequency of cardiovascular-related hospitalization, change from baseline in NT-proBNP, and change from baseline in 6MWT over a 30-month fixed treatment duration
Each subject will be compared to every other subject within a stratum over outcomes of all-cause mortality (death due to any cause), cumulative frequency of cardiovascular-related hospitalizations (number of times a subject is hospitalized for cardiovascular-related causes), change from baseline in NT-proBNP, and change from baseline in the total distance walked in 6 minutes (distance in meters). The hierarchical approach with the Finkelstein-Schoenfeld test will be applied and the test recognizes the greater importance of the mortality endpoint. Scores are transformed to -1, 0, +1. The alternative hypothesis is a subject in the acoramidis treatment group will have a greater score than a subject in the placebo group.

Secondary Outcome Measures

Evaluate effects of acoramidis on quality of life (QoL) through Month 12
Change from Baseline to Month 12 as measured in the Kansas City Cardiomyopathy Questionnaire Overall Summary score (KCCQ-OS). The KCCQ is a 23-item questionnaire developed to measure health status and health-related quality of life in subjects with heart failure. Items include heart failure symptoms, impact on physical and social functions, and how their heart failure impacts their quality of life (QoL). An Overall Summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, scores are transformed to a range of 0-100 using the formula, 100*[(mean of questions actually answered) - 1]/4, in which higher scores reflect better health status. The Overall Summary score is the mean of the domains scores, range from 0 to 100, in which higher scores reflect better health status.
Evaluate 6-Minute Walk Test (6MWT) through Month 30
Change from baseline to Month 30 of treatment in the total distance walked in 6 minutes
Evaluate effects of acoramidis on quality of life (QoL) through Month 30
Change from Baseline to Month 30 as measured in the Kansas City Cardiomyopathy Questionnaire Overall Summary score (KCCQ-OS). The KCCQ is a 23-item questionnaire developed to measure health status and health-related quality of life in subjects with heart failure. Items include heart failure symptoms, impact on physical and social functions, and how their heart failure impacts their quality of life (QoL). An Overall Summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, scores are transformed to a range of 0-100 using the formula, 100*[(mean of questions actually answered) - 1]/4, in which higher scores reflect better health status. The Overall Summary score is the mean of the domains scores, range from 0 to 100, in which higher scores reflect better health status.
Assess PD effects of circulating prealbumin by in vivo biomarker stabilization through Month 30
Change from baseline to Month 30 in serum TTR (prealbumin) level (an in vivo measure of TTR stabilization)
Assess all-cause mortality
All-Cause Mortality by Month 30 including death due to any cause, heart transplant, or CMAD
Assess safety and tolerability through Month 12
Safety parameters to be assessed: treatment- emergent serious adverse events (SAEs) and adverse events (AEs), AEs leading to treatment discontinuation, abnormal physical exam findings of clinical relevance, abnormal vital signs of clinical relevance, abnormal ECG parameters of clinical relevance, and changes in clinical safety laboratory parameters of potential clinical concern
PD assessments of TTR stabilization through Month 12
Change from baseline in TTR (prealbumin) level (an in vivo measure of TTR stabilization) at Month 12 TTR stabilization as measured in established ex-vivo assays (fluorescent probe exclusion [FPE] and Western blot) at Month 12 in the PK-PD substudy
Efficacy by individual components and hierarchical combinations through Month 30
A hierarchical combination of All-Cause mortality and cumulative frequency of CV-related hospitalization over a 30-month fixed treatment duration A hierarchical combination of All-Cause mortality, cumulative frequency of CV-related hospitalization, and change from baseline in 6MWT over a 30-month fixed treatment duration Change in NT-proBNP from baseline to Month 30 of treatment Cumulative frequency of CV-related hospitalization by Month 30
Efficacy of acoramidis in reducing CV mortality
Total number of deaths adjudicated as being related to cardiovascular causes
Incidence of treatment-emergent events
Assessment of incidence of treatment- emergent serious adverse events (SAEs) and adverse events (AEs)

Full Information

First Posted
February 27, 2019
Last Updated
July 6, 2023
Sponsor
Eidos Therapeutics, a BridgeBio company
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1. Study Identification

Unique Protocol Identification Number
NCT03860935
Brief Title
Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy
Acronym
ATTRibute-CM
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects With Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTRibute-CM Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
May 11, 2023 (Actual)
Study Completion Date
May 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eidos Therapeutics, a BridgeBio company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase 3 efficacy and safety study to evaluate acoramidis (AG10) HCl 800 mg administered orally twice a day compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
Detailed Description
Transthyretin amyloid cardiomyopathy (ATTR-CM) is an underdiagnosed condition believed to affect more than 400,000 people worldwide. In ATTR-CM, the accumulation of transthyretin (TTR) amyloid results in thickening and stiffening of the heart, which often leads to heart failure or even death. There are two forms of ATTR-CM: Wild Type* This form of the condition primarily develops in older individuals who do not carry gene mutations. Hereditary* This form of the condition comes from gene mutations passed down in families. In this study we are researching the investigational drug acoramidis HCl 800 mg administered orally twice a day. Through the study, we want to evaluate the efficacy and safety of acoramidis in patients with ATTR-CM versus placebo. This is a 30 month, randomized, double-blind, placebo-controlled study. This means that, during the 30 month study, investigators conducting the research and study participants will not know whether the study participant is receiving acoramidis or placebo. The primary outcomes of the study are: The impact of acoramidis versus placebo on the change in distance walked on the 6 minute walk test (6MWT) after 12 months of treatment compared to baseline. The impact of acoramidis versus placebo on the hierarchical combination of All-Cause mortality, cumulative frequency of cardiovascular-related hospitalizations, change from baseline in NT-proBNP, and change in from baseline in 6MWT over a 30-month fixed treatment duration. At the end of 30 months, participants may be eligible to receive investigational acoramidis, and there is no placebo. This is called an "open label extension." This separate study may help us better understand the safety related to taking acoramidis over a longer period of time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis, Cardiomyopathies, Heart Diseases
Keywords
Amyloidosis, ATTR-CM, Transthyretin, Amyloid, TTR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
632 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acoramidis HCl 800 mg
Arm Type
Experimental
Arm Description
Subjects will receive acoramidis HCl 800 mg twice daily. 6MWT primary outcome will be assessed at the end of 12 months. The hierarchical combination of All-Cause mortality, cumulative frequency of cardiovascular-related hospitalizations, change from baseline in NT-proBNP levels, and change from baseline in distance walked on the 6MWT will be assessed after 30 months of treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo to match twice daily. 6MWT primary outcome will be assessed at the end of 12 months. The hierarchical combination of All-Cause mortality, cumulative frequency of cardiovascular-related hospitalizations, change from baseline in NT-proBNP levels, and change from baseline in distance walked on the 6MWT will be assessed after 30 months of treatment.
Intervention Type
Drug
Intervention Name(s)
acoramidis
Other Intervention Name(s)
AG10, ALXN2060
Intervention Description
TTR stabilizer administered orally twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Non-active control administered orally twice daily (BID)
Primary Outcome Measure Information:
Title
6-Minute Walk Test (6MWT) through Month 12
Description
Change from baseline to Month 12 of treatment in the total distance walked in 6 minutes
Time Frame
12 months
Title
A hierarchical combination of all-cause mortality, cumulative frequency of cardiovascular-related hospitalization, change from baseline in NT-proBNP, and change from baseline in 6MWT over a 30-month fixed treatment duration
Description
Each subject will be compared to every other subject within a stratum over outcomes of all-cause mortality (death due to any cause), cumulative frequency of cardiovascular-related hospitalizations (number of times a subject is hospitalized for cardiovascular-related causes), change from baseline in NT-proBNP, and change from baseline in the total distance walked in 6 minutes (distance in meters). The hierarchical approach with the Finkelstein-Schoenfeld test will be applied and the test recognizes the greater importance of the mortality endpoint. Scores are transformed to -1, 0, +1. The alternative hypothesis is a subject in the acoramidis treatment group will have a greater score than a subject in the placebo group.
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Evaluate effects of acoramidis on quality of life (QoL) through Month 12
Description
Change from Baseline to Month 12 as measured in the Kansas City Cardiomyopathy Questionnaire Overall Summary score (KCCQ-OS). The KCCQ is a 23-item questionnaire developed to measure health status and health-related quality of life in subjects with heart failure. Items include heart failure symptoms, impact on physical and social functions, and how their heart failure impacts their quality of life (QoL). An Overall Summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, scores are transformed to a range of 0-100 using the formula, 100*[(mean of questions actually answered) - 1]/4, in which higher scores reflect better health status. The Overall Summary score is the mean of the domains scores, range from 0 to 100, in which higher scores reflect better health status.
Time Frame
12 months
Title
Evaluate 6-Minute Walk Test (6MWT) through Month 30
Description
Change from baseline to Month 30 of treatment in the total distance walked in 6 minutes
Time Frame
30 months
Title
Evaluate effects of acoramidis on quality of life (QoL) through Month 30
Description
Change from Baseline to Month 30 as measured in the Kansas City Cardiomyopathy Questionnaire Overall Summary score (KCCQ-OS). The KCCQ is a 23-item questionnaire developed to measure health status and health-related quality of life in subjects with heart failure. Items include heart failure symptoms, impact on physical and social functions, and how their heart failure impacts their quality of life (QoL). An Overall Summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, scores are transformed to a range of 0-100 using the formula, 100*[(mean of questions actually answered) - 1]/4, in which higher scores reflect better health status. The Overall Summary score is the mean of the domains scores, range from 0 to 100, in which higher scores reflect better health status.
Time Frame
30 months
Title
Assess PD effects of circulating prealbumin by in vivo biomarker stabilization through Month 30
Description
Change from baseline to Month 30 in serum TTR (prealbumin) level (an in vivo measure of TTR stabilization)
Time Frame
30 months
Title
Assess all-cause mortality
Description
All-Cause Mortality by Month 30 including death due to any cause, heart transplant, or CMAD
Time Frame
30 months
Title
Assess safety and tolerability through Month 12
Description
Safety parameters to be assessed: treatment- emergent serious adverse events (SAEs) and adverse events (AEs), AEs leading to treatment discontinuation, abnormal physical exam findings of clinical relevance, abnormal vital signs of clinical relevance, abnormal ECG parameters of clinical relevance, and changes in clinical safety laboratory parameters of potential clinical concern
Time Frame
12 months
Title
PD assessments of TTR stabilization through Month 12
Description
Change from baseline in TTR (prealbumin) level (an in vivo measure of TTR stabilization) at Month 12 TTR stabilization as measured in established ex-vivo assays (fluorescent probe exclusion [FPE] and Western blot) at Month 12 in the PK-PD substudy
Time Frame
12 months
Title
Efficacy by individual components and hierarchical combinations through Month 30
Description
A hierarchical combination of All-Cause mortality and cumulative frequency of CV-related hospitalization over a 30-month fixed treatment duration A hierarchical combination of All-Cause mortality, cumulative frequency of CV-related hospitalization, and change from baseline in 6MWT over a 30-month fixed treatment duration Change in NT-proBNP from baseline to Month 30 of treatment Cumulative frequency of CV-related hospitalization by Month 30
Time Frame
30 months
Title
Efficacy of acoramidis in reducing CV mortality
Description
Total number of deaths adjudicated as being related to cardiovascular causes
Time Frame
30 months
Title
Incidence of treatment-emergent events
Description
Assessment of incidence of treatment- emergent serious adverse events (SAEs) and adverse events (AEs)
Time Frame
30 months
Other Pre-specified Outcome Measures:
Title
Effects of acoramidis on circulating biomarker of myocardial wall stress
Description
Changes in level of NT-proBNP
Time Frame
12 months
Title
Effects of acoramidis on circulating biomarker of microvascular ischemia
Description
Changes in level of Troponin I (TnI)
Time Frame
12 months and 30 months
Title
Characterize PK of acoramidis
Description
PK measures of acoramidis and its predominant metabolite after oral administration of acoramidis HCl 800 mg BID for steady state (every 3 months), in a subgroup of subjects followed at centers participating in the PK-PD substudy
Time Frame
12 months and 30 months
Title
Evaluate effect of acoramidis on health-related quality of life questionnaire EuroQol EQ-5D-5L
Description
Change from Baseline to Month 30 in the EQ-5D-5L score. EQ-5D-5L consists of 2 parts: EQ-5D descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D comprises five dimensions: mobility, self-care, usual activities, pain or discomfort and anxiety or depression. Each dimension in EQ-5D-5L has five response levels of function: no problem (Level 1); slight problem (Level 2); moderate problem (Level 3); severe problem (Level 4); and extreme problem (Level 5). The subject is asked to indicate his health state by ticking the box next to the most appropriate statement in each of the five dimensions. The digits for the five dimensions can be combined into a 5-digit number, the utility score, that describes the subject's health state. A lower value indicates better perceived health state. On EQ VAS, the subject circles a single rating of self-perceived health on a 0 to 100 mm scale representing "the worst imaginable health state" and "the best imaginable health state", respectively.
Time Frame
12 months and 30 months
Title
Assess acoramidis activity across TTR mutations
Description
Acoramidis binding to or stabilization across a panel of TTR mutations by additional assays
Time Frame
12 months and 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have an established diagnosis of ATTR-CM with either wild-type TTR or variant TTR genotype Have a history of heart failure evidenced by at least one prior hospitalization for heart failure or clinical evidence of heart failure without prior heart failure hospitalization manifested by signs or symptoms of volume overload or elevated intracardiac pressures or heart failure symptoms that required or require ongoing treatment with a diuretic. New York Heart Association (NYHA) Class I-III symptoms due to ATTR cardiomyopathy. On stable doses of cardiovascular medical therapy Completed ≥150 m on the 6MWT on 2 tests that are within 15% of total distance walked prior to randomization Biomarkers of myocardial wall stress, NT-proBNP level ≥300 pg/mL at screening Have left ventricular wall (interventricular septum or left ventricular posterior wall) thickness ≥12 mm Exclusion Criteria: Had acute myocardial infarction, acute coronary syndrome or coronary revascularization, or experienced stroke or transient ischemic attack within 90 days prior to screening Has hemodynamic instability Likely to undergo heart transplantation within a year of screening Confirmed diagnosis of primary (light chain) amyloidosis Biomarkers of myocardial wall stress, NT-proBNP level ≥8500 pg/mL at screening Measure of kidney function, eGFR by MDRD formula <15 mL/min/1.73 m2 Current treatment with marketed drug products and other investigational agents for the treatment of ATTR-CM Current treatment with calcium channel blockers with conduction system effects (e.g. verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digitalis will only be allowed if required for management of atrial fibrillation with rapid ventricular response
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pacific Heart Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Colorado Hospital - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06473
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Miami - Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Piedmont Heart Institute Athens
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
Facility Name
Emory Heart and Vascular Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
NorthShore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
MedStar Medical Group Cardiology at Franklin Square Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Saint Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Saint Luke's Hospital - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
New York University Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10034
Country
United States
Facility Name
Laurelton Heart Specialist
City
Rosedale
State/Province
New York
ZIP/Postal Code
11422
Country
United States
Facility Name
University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
The Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Prisma Health - Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Carilion Clinic Roanoke Heart Institute
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Providence Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
Country
Australia
Facility Name
Saint Vincent's Hospital Sydney
City
Sydney
ZIP/Postal Code
2010
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
Country
Australia
Facility Name
Ziekenhuis Oost-Limburg - Campus Sint-Jan
City
Genk
State/Province
Limburg
Country
Belgium
Facility Name
Jessa Ziekenhuis - Campus Virga Jesse
City
Hasselt
State/Province
Limburg
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
City
Brugge
State/Province
West Vlaanderen
Country
Belgium
Facility Name
Onze-Lieve-Vrouw Ziekenhuis Aalst
City
Aalst
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
Country
Belgium
Facility Name
Hospital Cárdio Pulmonar
City
Salvador
State/Province
Bahia
Country
Brazil
Facility Name
Santa Casa de Misericordia - Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
CAPED - Centro Avançado de Pesquisa e Estudos para o Diagnóstico
City
Ribeirão Preto
State/Province
Sao Paulo
ZIP/Postal Code
14026-900
Country
Brazil
Facility Name
INCOR
City
São Paulo
State/Province
Sao Paulo
Country
Brazil
Facility Name
Instituto de Cardiologia do Rio Grande do Sul
City
Porto Alegre
Country
Brazil
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
CancerCare Manitoba - St. Boniface
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Halifax Infirmary
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Toronto Heart Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4P 1E4
Country
Canada
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Centre Hospitalier de L'Universite de Montreal - Hôpital Notre-Dame
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3H8
Country
Canada
Facility Name
Hôpital du Sacré-Coeur de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Hôpital régional de Rimouski
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
Montreal Heart Institute
City
Montréal
Country
Canada
Facility Name
St. Anne´s University Hospital
City
Brno Střed
Country
Czechia
Facility Name
General University Hospital in Prague
City
Nové Město
Country
Czechia
Facility Name
Institute for Clinical and Experimental Medicine
City
Prague
Country
Czechia
Facility Name
Aarhus Universitetshospital
City
Aarhus
State/Province
Dinamarca
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Alexandra General Hospital of Athens
City
Athens
State/Province
Attica
Country
Greece
Facility Name
Mater Misericordiae University Hospital
City
Dublin
Country
Ireland
Facility Name
Saint Vincents University Hospital
City
Dublin
Country
Ireland
Facility Name
Hadassah University Hospital Ein Kerem
City
Jerusalem
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel Hashomer
Country
Israel
Facility Name
Ospedale San Donato
City
Arezzo
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
City
Bologna
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Careggi
City
Firenze
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanità Pubblica
City
Pisa
Country
Italy
Facility Name
Ospedale degli Infermi
City
Rimini
Country
Italy
Facility Name
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
City
Roma
Country
Italy
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-Do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Gyeonggi-Do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Maastricht Universitair Medisch Centrum
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
Country
Netherlands
Facility Name
Middlemore Hospital
City
Otahuhu
State/Province
Auckland
ZIP/Postal Code
1640
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
National Institute of Cardiology
City
Warsaw
Country
Poland
Facility Name
Centro Hospitalar de Lisboa Norte EPE- Hospital Santa Maria
City
Lisboa
Country
Portugal
Facility Name
Centro Hospitalar do Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Clínica Universidad de Navarra
City
Pamplona
State/Province
Navarra
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Barcelona
Country
Spain
Facility Name
Hospital Juan Ramón Jiménez
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Facility Name
Hospital Juan Ramón Jiménez
City
Huelva
Country
Spain
Facility Name
Clinica Universidad de Navarra Madrid
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
Country
Spain
Facility Name
Hospital Son Llàtzer
City
Palma De Mallorca
Country
Spain
Facility Name
Hospital Clínico Universitario de Santiago de Compostela
City
Santiago De Compostela
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
Country
Spain
Facility Name
Royal Free Hospital
City
London
State/Province
England
ZIP/Postal Code
NW3 2PF
Country
United Kingdom
Facility Name
Richmond Pharmacology
City
London
ZIP/Postal Code
SE1 1YR
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33725199
Citation
Stern LK, Kittleson MM. Updates in Cardiac Amyloidosis Diagnosis and Treatment. Curr Oncol Rep. 2021 Mar 16;23(4):47. doi: 10.1007/s11912-021-01028-8.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy

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