Clinical trials: Amyloidosis Cardiac
AL Amyloidosis
The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who…
- Trial name
- PRONTO (NCT02632786)
- Testing
- NEOD001
- Where
- 40 sites in United States, Australia and 8 more
- Volunteers
- 129 people
- Sponsor
- Prothena Biosciences Ltd.
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Korean Post-marketing Surveillance Vyndamax® Capsules for the Treatment of Transthyretin Amyloid Cardiomyopathy
This non-interventioal study will be performed by design of post-marketing surveillance (PMS) as an additional pharmacovigilance activity of the Risk Management Plan (RMP) for Vyndamax® Capsules, which is required by the Ministry…
- Trial name
- NCT04801329
- Testing
- Vyndamax (tafamidis 61mg)
- Where
- South Korea
- Volunteers
- 110 people
- Sponsor
- Pfizer
HFpEF - Heart Failure With Preserved Ejection Fraction, HFmrEF
US Benchmarking Clinical Study
The goal of this observational study is to measure shear wave velocity (SWV) in patients with non-reduced left ventricular ejection fraction (LVEF) heart failure and left ventricular hypertrophy, with or without transthyretin…
- Conditions
- HFpEF - Heart Failure With Preserved Ejection Fraction, HFmrEF, ATTR-CM (Transthyretin Amyloid Cardiomyopathy), Left Ventricular Hypertrophy
- Trial name
- EMS-CT-1 (NCT07215715)
- Where
- 3 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- eMyosound SAS
Transthyretin Amyloidosis
The Eplontersen Pregnancy and Lactation Outcomes Study
The overall objective of this DPSS is to describe the occurrence of pregnancy and maternal complications, adverse effects on the developing fetus and neonate, and adverse effects on the infant associated with exposure to…
- Trial name
- EPPRO (NCT07205666)
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- AstraZeneca
Cardiac Amyloidosis, AL Amyloidosis
Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis
This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with suspected cardiac…
- Conditions
- Cardiac Amyloidosis, AL Amyloidosis, ATTR Amyloidosis
- Trial name
- CArdiag (NCT05184088)
- Testing
- [18F]florbetaben
- Where
- 14 sites in United States, Germany and 2 more
- Volunteers
- 244 people
- Sponsor
- Lantheus Germany GmbH
Transthyretin Gene Mutations, Transthyretin Amyloidosis
Transthyretin Amyloidosis Outcome Survey (THAOS)
THAOS is a global, multi-center, longitudinal observational survey open to all patients with transthyretin amyloidosis (ATTR), including ATTR-PN (polyneuropathy), ATTR-CM (cardiomyopathy) and wild-type ATTR-CM.
- Trial name
- THAOS (NCT00628745)
- Testing
- None. Observational Study.
- Where
- 113 sites in United States, Argentina and 23 more
- Volunteers
- 6,718 people
- Sponsor
- Pfizer
Transthyretin Amyloidosis With Cardiomyopathy
TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
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…
- Trial name
- NCT07052903
- Testing
- Nucresiran, Sterile Normal Saline (0.9% NaCl)
- Where
- 266 sites in United States, Argentina and 34 more
- Volunteers
- 1,750 people
- Sponsor
- Alnylam Pharmaceuticals
Transthyretin Amyloidosis Polyneuropathy, Transthyrexin Amyloidosis Cardiomyopathy
A Phase I/IIa，Open-label, Single Ascending Dose and Dose-expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of YOLT-201 in Patients With Transthyretin Amyloidosis Polyneuropathy (ATTR-PN) or Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
This study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of YOLT-201 in participants with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN) and…
- Trial name
- NCT06539208
- Testing
- YOLT-201
- Where
- 3 sites in China
- Volunteers
- 31 people
- Sponsor
- YolTech Therapeutics Co., Ltd
Plaque, Atherosclerotic Disease
BioImage Study: A Clinical Study of Burden of Atherosclerotic Disease in an At-Risk Population
The BioImage Study is a study of the characteristics of subclinical cardiovascular disease, as measured by imaging modalities, unsupervised circulating biomarker measurements, and risk factors that predict progression to overt…
- Conditions
- Plaque, Atherosclerotic Disease, Heart Disease, Stroke
- Trial name
- NCT00738725
- Where
- 2 sites in United States
- Volunteers
- 7,687 people, healthy volunteers welcome
- Sponsor
- BG Medicine, Inc
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
The purpose of this study is to obtain safety, efficacy, and pharmacodynamic data on the use of vutrisiran in patients with ATTR amyloidosis with cardiomyopathy who continued on extended use of vutrisiran, or switched from…
- Trial name
- NCT06679946
- Testing
- Vutrisiran
- Where
- 87 sites in United States, Argentina and 15 more
- Volunteers
- 700 people
- Sponsor
- Alnylam Pharmaceuticals
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
To evaluate the efficacy of eplontersen compared to placebo in participants with ATTR-CM receiving available standard of care (SoC).
- Trial name
- NCT04136171
- Testing
- Eplontersen
- Where
- 139 sites in United States, Argentina and 19 more
- Volunteers
- 1,438 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Amyloid Cardiomyopathy, Transthyretin-Related
Single and Multiple Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of AG10
This is a single center, prospective, randomized, placebo-controlled study of AG10 in healthy adult subjects
- Trial name
- NCT03294707
- Testing
- AG10 oral tablet
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Eidos Therapeutics, a BridgeBio company
Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Real-World Effectiveness of High-Dose Tafamidis on Neurologic Disease Progression in Mixed-Phenotype Transthyretin Amyloid Cardiomyopathy
This study will examine the clinical effectiveness of Tafamidis in patients with Mixed Phenotype Transthyretin Amyloidosis using data that already exist in patients' medical records
- Trial name
- NCT06393465
- Testing
- Tafamidis
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Pfizer
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.
- Trial name
- NCT05667493
- Testing
- Eplontersen
- Where
- 134 sites in United States, Argentina and 18 more
- Volunteers
- 1,400 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Alpha-Thalassemia, Beta-Thalassemia
FLOWER: Following Longitudinal Outcomes With Epidemiology for Rare Diseases
FLOWER is a completely virtual, nationwide, real-world observational study to collect, annotate, standardize, and report clinical data for rare diseases.
- Conditions
- Alpha-Thalassemia, Beta-Thalassemia, Amyloidosis, Amyotrophic Lateral Sclerosis
- Trial name
- NCT06539169
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- xCures
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
The CARDIO-TTRansform Scintigraphy Sub-study
The purpose of this study is to examine the changes in amyloid myocardial burden in a subset of the population participating in the ION682884-CS2 (NCT04136171) study, up to 150 participants, after treatment with eplontersen or…
- Trial name
- NCT06073587
- Testing
- Scintigraphy scan
- Where
- 5 sites in United States, Spain
- Volunteers
- 163 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Transthyretin Amyloid Cardiomyopathy ("ATTR-CM")
A Prospective Study to Assess the Utility of CA-4F in a Canadian Cardiology Setting
This study will assess whether CA-4F can improve diagnosis of ATTR-CM in a community cardiology setting when used to screen electronic medical record data for patients suitable for follow-up investigations.
- Trial name
- NCT05210010
- Testing
- CA-4F
- Where
- 3 sites in Canada
- Volunteers
- 8 people
- Sponsor
- Ensho Health Intelligent Systems Inc.
Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor
Transthyretin amyloid cardiomyopathy (ATTR-CM) is a heart condition caused by a protein called transthyretin (TTR) building up as amyloid in the heart muscle.
- Trial name
- ACO-MONITOR (NCT07557147)
- Testing
- Luscii
- Where
- 3 sites in Austria, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Bayer
Transthyretin Amyloid Cardiomyopathy
A Study to Assess the Safety and Efficacy Of Tafamidis In Chinese Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
This is a national, multi-center, single-arm study, open-label to patients with symptomatic Transthyretin amyloid cardiomyopathy (ATTR-CM) who are tafamidis naïve.
- Trial name
- NCT04814186
- Testing
- Tafamidis
- Where
- 9 sites in China
- Volunteers
- 53 people
- Sponsor
- Pfizer
Transthyretin Amyloid Cardiomyopathy (ATTR CM)
A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis
This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR…
- Trial name
- NCT06260709
- Testing
- NNC6019-0001
- Where
- 38 sites in United States, Canada and 8 more
- Volunteers
- 88 people
- Sponsor
- Novo Nordisk A/S