Clinical Trial
Study Details
Sterile Normal Saline (0.9% NaCl) administered SC once q6M
Outcomes
All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits) will be compared between treatment groups using an Andersen-Gill model.
The KCCQ is a 23-item self-administered questionnaire quantifying 6 domains (symptoms, physical function, quality of life, social limitation, self-efficacy, and symptom stability) and 2 summary scores (clinical and overall summary \[OS\]). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Study Overview
The purpose of this study is to:
* Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and cardiovascular (CV) events
* Evaluate the efficacy of nucresiran compared to placebo on additional assessments of CV events and/or death
* Evaluate the efficacy of nucresiran compared to placebo on patient-reported health status and health-related quality of life
Contacts and Locations
Clinical Trial Site
La Jolla, California 92037
United States
Clinical Trial Site
Laguna Hills, California 92653
United States
Clinical Trial Site
Stanford, California 94305
United States
Clinical Trial Site
Aurora, Colorado 80045
United States
Clinical Trial Site
Norwich, Connecticut 06360
United States
Clinical Trial Site
Washington D.C., District of Columbia 20010
United States
Clinical Trial Site
Brandon, Florida 33511
United States
Clinical Trial Site
Miami, Florida 33125
United States
Clinical Trial Site
Atlanta, Georgia 30309
United States
Clinical Trial Site
Gainesville, Georgia 30501
United States
Clinical Trial Site
Tucker, Georgia 30084
United States
Clinical Trial Site
Chicago, Illinois 60612
United States
Clinical Trial Site
Evanston, Illinois 60201
United States
Clinical Trial Site
Indianapolis, Indiana 46202
United States
Clinical Trial Site
Indianapolis, Indiana 46260
United States
Clinical Trial Site
Kansas City, Kansas 66160
United States
Clinical Trial Site
Baltimore, Maryland 21287
United States
Clinical Trial Site
Boston, Massachusetts 02115
United States
Clinical Trial Site
Boston, Massachusetts 02118
United States
Clinical Trial Site
Detroit, Michigan 48202
United States
Clinical Trial Site
Rochester, Minnesota 55905
United States
Clinical Trial Site
St Louis, Missouri 63110
United States
Clinical Trial Site
Manhasset, New York 11030
United States
Clinical Trial Site
New York, New York 10029
United States
Clinical Trial Site
New York, New York 10032
United States
Clinical Trial Site
New York, New York 10065
United States
Clinical Trial Site
The Bronx, New York 10467
United States
Clinical Trial Site
Charlotte, North Carolina 28204
United States
Clinical Trial Site
Cleveland, Ohio 44195
United States
Clinical Trial Site
Columbus, Ohio 43210
United States
Clinical Trial Site
Portland, Oregon 97239
United States
Clinical Trial Site
Lancaster, Pennsylvania 17602
United States
Clinical Trial Site
Philadelphia, Pennsylvania 19104
United States
Clinical Trial Site
Charleston, South Carolina 29425
United States
Clinical Trial Site
Austin, Texas 78705
United States
Clinical Trial Site
Dallas, Texas 75246
United States
Clinical Trial Site
Houston, Texas 77030
United States
Clinical Trial Site
Plano, Texas 75024
United States
Clinical Trial Site
Salt Lake City, Utah 84132
United States
Clinical Trial Site
Charlottesville, Virginia 22903
United States
Clinical Trial Site
Falls Church, Virginia 22042
United States
Clinical Trial Site
Norfolk, Virginia 23507
United States
Clinical Trial Site
Richmond, Virginia 23298
United States
Clinical Trial Site
Seattle, Washington 98195
United States
Clinical Trial Site
Spokane, Washington 99204
United States
Clinical Trial Site
C1025ABI Buenos Aires
Argentina
Clinical Trial Site
C1093AAS Buenos Aires
Argentina
Clinical Trial Site
C1199ABB Buenos Aires
Argentina
Clinical Trial Site
C1428 Buenos Aires
Argentina
Clinical Trial Site
X5016KET Córdoba
Argentina
Clinical Trial Site
S2000DEJ Rosario
Argentina
Clinical Trial Site
S2000DSR Rosario
Argentina
Clinical Trial Site
S2000GAP Rosario
Argentina
Clinical Trial Site
Adelaide 5000
Australia
Clinical Trial Site
Bedford Park 5042
Australia
Clinical Trial Site
Box Hill 3128
Australia
Clinical Trial Site
Chermside 4032
Australia
Clinical Trial Site
Darlinghurst 2010
Australia
Clinical Trial Site
Joondalup 6027
Australia
Clinical Trial Site
Liverpool 2170
Australia
Clinical Trial Site
Westmead 2145
Australia
Clinical Trial Site
5280 Braunau am Inn
Austria
Clinical Trial Site
8036 Graz
Austria
Clinical Trial Site
1090 Vienna
Austria
Clinical Trial Site
1100 Vienna
Austria
Clinical Trial Site
1160 Vienna
Austria
Clinical Trial Site
1210 Vienna
Austria
Clinical Trial Site
4600 Wels
Austria
Clinical Trial Site
9300 Aalst
Belgium
Clinical Trial Site
8000 Bruges
Belgium
Clinical Trial Site
1200 Brussels
Belgium
Clinical Trial Site
9200 Dendermonde
Belgium
Clinical Trial Site
2650 Edegem
Belgium
Clinical Trial Site
3600 Genk
Belgium
Clinical Trial Site
9000 Ghent
Belgium
Clinical Trial Site
3500 Hasselt
Belgium
Clinical Trial Site
3000 Leuven
Belgium
Clinical Trial Site
4000 Liège
Belgium
Clinical Trial Site
8800 Roeselare
Belgium
Clinical Trial Site
Belo Horizonte
30220-140
Brazil
Clinical Trial Site
Campinas
13083-888
Brazil
Clinical Trial Site
Porto Alegre
90035-903
Brazil
Clinical Trial Site
Porto Alegre
90560-032
Brazil
Clinical Trial Site
Recife
50070-480
Brazil
Clinical Trial Site
Ribeirão Preto
14026-900
Brazil
Clinical Trial Site
Ribeirão Preto
14051-140
Brazil
Clinical Trial Site
Rio de Janeiro
20551-030
Brazil
Clinical Trial Site
Rio de Janeiro
22280-020
Brazil
Clinical Trial Site
Salvador
40170-130
Brazil
Clinical Trial Site
São Paulo
04038-002
Brazil
Clinical Trial Site
São Paulo
05403-000
Brazil
Clinical Trial Site
Calgary T2N 4N1
Canada
Clinical Trial Site
London N6A 5A5
Canada
Clinical Trial Site
Toronto M4P 1E4
Canada
Clinical Trial Site
Vancouver V6Z 1Y6
Canada
Clinical Trial Site
7500588 Santiago
Chile
Clinical Trial Site
8320000 Santiago
Chile
Clinical Trial Site
Binhai
300456
China
Clinical Trial Site
Changsha
410011
China
Clinical Trial Site
Changsha
410013
China
Clinical Trial Site
Chengdu
610041
China
Clinical Trial Site
Dongcheng
100006
China
Clinical Trial Site
Fuzhou
350004
China
Clinical Trial Site
Guangzhou
510080
China
Clinical Trial Site
Haidian
100191
China
Clinical Trial Site
Hangzhou
310009
China
Clinical Trial Site
Hangzhou
310014
China
Clinical Trial Site
Hefei
230061
China
Clinical Trial Site
Hexi District
300211
China
Clinical Trial Site
Jinan
271000
China
Clinical Trial Site
Nanchang
330030
China
Clinical Trial Site
Nangang
150001
China
Clinical Trial Site
Nanjing
210029
China
Clinical Trial Site
Shenzhen Shi
518053
China
Clinical Trial Site
Taiyuan
030012
China
Clinical Trial Site
Wuhan
430064
China
Clinical Trial Site
Xicheng
100034
China
Clinical Trial Site
Yuanjiagang
400016
China
Clinical Trial Site
602 00 Brno
Czechia
Clinical Trial Site
708-52 Ostrava
Czechia
Clinical Trial Site
128 21 Prague
Czechia
Clinical Trial Site
140 21 Prague
Czechia
Clinical Trial Site
8200 Aarhus N
Denmark
Clinical Trial Site
2100 København Ø
Denmark
Clinical Trial Site
5000 Odense C
Denmark
Clinical Trial Site
37170 Chambray-lès-Tours
France
Clinical Trial Site
94000 Créteil
France
Clinical Trial Site
21000 Dijon
France
Clinical Trial Site
38700 La Tronche
France
Clinical Trial Site
13005 Marseille
France
Clinical Trial Site
97261 Martinique
France
Clinical Trial Site
34295 Montpellier
France
Clinical Trial Site
75015 Paris
France
Clinical Trial Site
75018 Paris
France
Clinical Trial Site
33600 Pessac
France
Clinical Trial Site
51100 Reims
France
Clinical Trial Site
35000 Rennes
France
Clinical Trial Site
76031 Rouen
France
Clinical Trial Site
44093 Saint-Herblain
France
Clinical Trial Site
67091 Strasbourg
France
Clinical Trial Site
31059 Toulouse
France
Clinical Trial Site
13353 Berlin
Germany
Clinical Trial Site
50937 Cologne
Germany
Clinical Trial Site
01307 Dresden
Germany
Clinical Trial Site
37075 Göttingen
Germany
Clinical Trial Site
30625 Hanover
Germany
Clinical Trial Site
69120 Heidelberg
Germany
Clinical Trial Site
04103 Leipzig
Germany
Clinical Trial Site
39120 Magdeburg
Germany
Clinical Trial Site
81377 Munich
Germany
Clinical Trial Site
48149 Münster
Germany
Clinical Trial Site
97080 Würzburg
Germany
Clinical Trial Site
115 27 Athens
Greece
Clinical Trial Site
115 28 Athens
Greece
Clinical Trial Site
714 09 Heraklion
Greece
Clinical Trial Site
546 36 Thessaloniki
Greece
Clinical Trial Site
Balatonfüred
8230
Hungary
Clinical Trial Site
Budapest
1085
Hungary
Clinical Trial Site
Dublin
D07 R2WY
Ireland
Clinical Trial Site
Dublin
D08 NHY1
Ireland
Clinical Trial Site
Be’er Ya‘aqov 70300
Israel
Clinical Trial Site
Haifa 3109601
Israel
Clinical Trial Site
Jerusalem 91120
Israel
Clinical Trial Site
Petah Tikva 4941492
Israel
Clinical Trial Site
60126 Ancona
Italy
Clinical Trial Site
40138 Bologna
Italy
Clinical Trial Site
25123 Brescia
Italy
Clinical Trial Site
50134 Florence
Italy
Clinical Trial Site
47121 Forlì
Italy
Clinical Trial Site
73100 Lecce
Italy
Clinical Trial Site
20122 Milan
Italy
Clinical Trial Site
80131 Naples
Italy
Clinical Trial Site
35128 Padova
Italy
Clinical Trial Site
27100 Pavia
Italy
Clinical Trial Site
56124 Pisa
Italy
Clinical Trial Site
47923 Rimini
Italy
Clinical Trial Site
00168 Roma
Italy
Clinical Trial Site
00161 Rome
Italy
Clinical Trial Site
10126 Torino
Italy
Clinical Trial Site
Bunkyō City
113-8655
Japan
Clinical Trial Site
Fukuoka
810-0001
Japan
Clinical Trial Site
Fukuoka
812-8582
Japan
Clinical Trial Site
Kagawa
761-0793
Japan
Clinical Trial Site
Kashihara
634-8522
Japan
Clinical Trial Site
Kobe
650-0017
Japan
Clinical Trial Site
Kumamoto
860-8556
Japan
Clinical Trial Site
Kurume
830-0011
Japan
Clinical Trial Site
Matsumoto-shi
390-8621
Japan
Clinical Trial Site
Nagoya
466-8560
Japan
Clinical Trial Site
Nankoku
783-0043
Japan
Clinical Trial Site
Niigata
951-8520
Japan
Clinical Trial Site
Okayama
700-8558
Japan
Clinical Trial Site
Sapporo
060-8543
Japan
Clinical Trial Site
Sapporo
060-8648
Japan
Clinical Trial Site
Sendai
980-8574
Japan
Clinical Trial Site
Suita
564-8565
Japan
Clinical Trial Site
Tokyo
160-8582
Japan
Clinical Trial Site
43000 Kajang
Malaysia
Clinical Trial Site
59100 Kuala Lumpur
Malaysia
Clinical Trial Site
14080 Tlalpan
Mexico
Clinical Trial Site
5623 EJ Eindhoven
Netherlands
Clinical Trial Site
9713 GZ Groningen
Netherlands
Clinical Trial Site
6229 HX Maastricht
Netherlands
Clinical Trial Site
3015 GD Rotterdam
Netherlands
Clinical Trial Site
3584 CX Utrecht
Netherlands
Clinical Trial Site
Auckland 2025
New Zealand
Clinical Trial Site
Christchurch 8011
New Zealand
Clinical Trial Site
Hamilton 3204
New Zealand
Clinical Trial Site
6017 Ålesund
Norway
Clinical Trial Site
1478 Lørenskog
Norway
Clinical Trial Site
93-338 Lodz
Poland
Clinical Trial Site
2790-134 Carnaxide
Portugal
Clinical Trial Site
4835-044 Creixomil
Portugal
Clinical Trial Site
2410-197 Leiria
Portugal
Clinical Trial Site
1169-024 Lisbon
Portugal
Clinical Trial Site
1649-035 Lisbon
Portugal
Clinical Trial Site
5000-508 Vila Real
Portugal
Clinical Trial Site
3504-509 Viseu
Portugal
Clinical Trial Site
022328 Bucharest
Romania
Clinical Trial Site
400001 Cluj-Napoca
Romania
Clinical Trial Site
040 11 Košice
Slovakia
Clinical Trial Site
Incheon
22332
South Korea
Clinical Trial Site
Seoul
03080
South Korea
Clinical Trial Site
Seoul
03722
South Korea
Clinical Trial Site
Seoul
06351
South Korea
Clinical Trial Site
Seoul
06591
South Korea
Clinical Trial Site
15006 A Coruña
Spain
Clinical Trial Site
08035 Barcelona
Spain
Clinical Trial Site
08036 Barcelona
Spain
Clinical Trial Site
48013 Bilbao
Spain
Clinical Trial Site
30120 El Palmar
Spain
Clinical Trial Site
21005 Huelva
Spain
Clinical Trial Site
23007 Jaén
Spain
Clinical Trial Site
8907 L'Hospitalet de Llobregat
Spain
Clinical Trial Site
25198 Lleida
Spain
Clinical Trial Site
28046 Madrid
Spain
Clinical Trial Site
28222 Madrid
Spain
Clinical Trial Site
07198 Palma de Mallorca
Spain
Clinical Trial Site
31008 Pamplona
Spain
Clinical Trial Site
37007 Salamanca
Spain
Clinical Trial Site
15706 Santiago de Compostela
Spain
Clinical Trial Site
46010 Valencia
Spain
Clinical Trial Site
46026 Valencia
Spain
Clinical Trial Site
36213 Vigo
Spain
Clinical Trial Site
413 45 Gothenburg
Sweden
Clinical Trial Site
222 42 Lund
Sweden
Clinical Trial Site
171 76 Solna
Sweden
Clinical Trial Site
4051 Basel
Switzerland
Clinical Trial Site
3010 Bern
Switzerland
Clinical Trial Site
1205 Geneva
Switzerland
Clinical Trial Site
6000 Lucerne
Switzerland
Clinical Trial Site
9007 Sankt Gallen
Switzerland
Clinical Trial Site
New Taipei City, 220
Taiwan
Clinical Trial Site
Taichung, 40705
Taiwan
Clinical Trial Site
Taipei, 10002
Taiwan
Clinical Trial Site
Taipei, 112
Taiwan
Clinical Trial Site
Bellshill
ML4 3NJ
United Kingdom
Clinical Trial Site
Birmingham
B15 2SQ
United Kingdom
Clinical Trial Site
Cardiff
CF15 9SS
United Kingdom
Clinical Trial Site
London
NW10 2PB
United Kingdom
Clinical Trial Site
London
NW3 2QG
United Kingdom
Clinical Trial Site
Manchester
M15 6SE
United Kingdom
Participation Criteria
Inclusion Criteria
* Has documented diagnosis of ATTR amyloidosis with cardiomyopathy including those with hereditary ATTR (hATTR) or wild-type ATTR (wATTR) amyloidosis.
* Has medical history of heart failure (HF) with at least 1 prior hospitalization for HF or signs and symptoms that require treatment with a diuretic.
* Has screening N-terminal prohormone B-type natriuretic peptide (NT-proBNP) \>300 ng/L and \<8500 ng/L; In patients with permanent or persistent atrial fibrillation, screening NT-proBNP \>600 ng/L and \<8500 ng/L.
* Patients may be receiving approved TTR stabilizers for ATTR amyloidosis (eg, tafamidis, acoramidis) and may be receiving background therapy for HF at the discretion of the Investigator.
Exclusion Criteria
* Has New York Heart Association (NYHA) Class IV HF; or NYHA Class III heart failure AND ATTR Amyloidosis Disease Stage 3.
* Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV.
* Has an estimated glomerular filtration rate eGFR of \<30 mL/min/1.73m\^2 at screening.
* Has received prior or currently receiving TTR-lowering therapy