Clinical trials: Amyloidosis Cardiac
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
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, Heart Failure With Preserved Ejection Fraction
Global Prevalence of ATTR-CM in Participants With HFpEF
This study is a global, multi-center study designed to estimate the global prevalence of transthyretin amyloid cardiomyopathy (ATTR-CM) within a clinically at risk population [participants with heart failure with preserved…
- Trial name
- NCT04424914
- Testing
- Scintigraphy
- Where
- 51 sites in United States, Canada and 6 more
- Volunteers
- 347 people
- Sponsor
- Pfizer
Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
A Study to Learn About the Use of Acoramidis in Patients With a Heart Condition Called Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in a Real-world Setting
Transthyretin Amyloid Cardiomyopathy (ATTR-CM) is a serious and life-threatening condition where a protein called transthyretin (TTR) misfolds and builds up as amyloid fibrils in the heart muscle.
- Trial name
- ACO-REAL (NCT07235462)
- Testing
- Acoramidis (356 mg film-coated tablets)
- Where
- 17 sites in Austria, Belgium and 15 more
- Volunteers
- 2,000 people
- Sponsor
- Bayer
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study
The main purpose of this study is to measure the amyloid burden, defined as extracellular volume (ECV) assessed by Magnetic Resonance Imaging (MRI) over time in a subset of up to 150 participants enrolled in ION-682884-CS2…
- Trial name
- NCT06073574
- Testing
- Cardiac MRI
- Where
- 11 sites in United States, Italy and 2 more
- Volunteers
- 160 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Transthyretin Amyloid Cardiomyopathy (ATTR CM)
A Research Study to Look at How a New Medicine Called NNC6019-0001 Works and How Safe it is for People Who Have Heart Disease Due to Transthyretin (TTR) Amyloidosis
This study is testing a potential new medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis.The study will look at if this medicine can reduce the symptoms of a heart disease due to TTR amyloidosis…
- Trial name
- NCT05442047
- Testing
- NNC6019-0001
- Where
- 39 sites in United States, Canada and 8 more
- Volunteers
- 105 people
- Sponsor
- Novo Nordisk A/S
Familial ATTR-CM (ATTRm-CM, or FAC), Wild-type ATTR-CM (ATTRwt-CM)
Study of AG10 in Amyloid Cardiomyopathy
This prospective, randomized, multicenter, double-blind, parallel group, placebo-controlled, dose-ranging study will evaluate the safety, tolerability, PK (Pharmacokinetic) and PD (Pharmacodynamic) of AG10 compared to placebo…
- Trial name
- NCT03458130
- Testing
- AG10
- Where
- 13 sites in United States
- Volunteers
- 49 people
- Sponsor
- Eidos Therapeutics, a BridgeBio company
Coronary Artery Disease
ELUCIDATE FFRct Study
The goal of this study is to evaluate the diagnostic accuracy of a novel plaque-based coronary CT angiography (CCTA) fractional flow reserve (FFRct) software device for the estimation of invasive fractional flow reserve (FFR).
- Trial name
- NCT06018194
- Testing
- ElucidVivo
- Where
- 8 sites in United States
- Volunteers
- 439 people
- Sponsor
- Elucid Bioimaging Inc.
ATTR-CM
A Retrospective Validation Study To Identify Chart-Based Clinical Diagnosis Of Wild-Type Transthyretin Amyloid Cardiomyopathy (Attrwt-CM) And Non-Amyloid Heart Failure Among Patients With Heart Failure (HF).
This is an observational, retrospective non-inferiority study with a study sample from a large national database. A machine learning (ML) model will use a national database to predict the clinical diagnosis of ATTRwt-CM among HF…
- Trial name
- NCT06029452
- Testing
- Machine learning algorithm
- Where
- United States
- Volunteers
- 558 people
- Sponsor
- Pfizer
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
Familial Amyloidotic Cardiomyopathy (FAC)
DISCOVERY: A Study Examining the Prevalence of TTR Mutations in Subjects Suspected of Having Cardiac Amyloidosis
The purpose of this study is to characterize the frequency of TTR mutations in subjects suspected of having cardiac amyloidosis
- Trial name
- NCT02252653
- Where
- 58 sites in United States, Belgium and 4 more
- Volunteers
- 1,010 people
- Sponsor
- Alnylam Pharmaceuticals
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.
Transthyretin Amyloid Cardiomyopathy
A Study to Learn About the Study Medicine Called Tafamidis 61mg in People Diagnosed With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
The purpose of this clinical trial is to learn about the effects of the study medicine (called Tafamidis 61milligrams (mg)) for the potential treatment of Transthyretin amyloid cardiomyopathy (ATTR-CM).
- Trial name
- NCT06321523
- Testing
- Tafamidis 61 milligrams
- Where
- 4 sites in South Korea
- Volunteers
- 13 people
- Sponsor
- Pfizer
Transthyretin Amyloid Cardiomyopathy
A Research Study to Look at the Distribution and Effects of Coramitug on Amyloid Deposits in Heart Tissue Using PET/CT Imaging in People With ATTR Amyloidosis.
The study is conducted in participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM), a heart disease that occurs in people with the disease ATTR amyloidosis.
- Trial name
- NCT07448623
- Testing
- Coramitug
- Where
- Netherlands
- Volunteers
- 14 people
- Sponsor
- Novo Nordisk A/S
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.
Transthyretin Amyloidosis, Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy
TRAMmoniTTR Study Genetic Screening of an At-risk Population for hATTR and Monitoring of TTR Positive Subjects
National, multicenter, epidemiological, longitudinal protocol to investigate the hATTR prevalence in an at-risk population for Hereditary Transthyretin Amyloidosis (hATTR) and subjects diagnosed with hATTR, to monitor the…
- Conditions
- Transthyretin Amyloidosis, Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy, Transthyretin-Related (ATTR) Familial Amyloid Cardiomyopathy, Polyneuropathies
- Trial name
- TRAMmoniTTR (NCT03237494)
- Where
- 84 sites in Austria, Germany and 1 more
- Volunteers
- 5,028 people
- Sponsor
- CENTOGENE GmbH Rostock
Transthyretin Amyloidosis With Cardiomyopathy
DemonsTTRate: A Global, Observational, Multicenter, Long-term Study of Patients With ATTR-CM in a Real-World Setting
The purpose of this study is to: Describe the clinical characteristics of adult patients with transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM) treated with vutrisiran in routine clinical care Describe treatment…
- Trial name
- DemonsTTRate (NCT07358078)
- Where
- 27 sites in United States, Germany and 1 more
- Volunteers
- 2,000 people
- Sponsor
- Alnylam Pharmaceuticals
ATTR-CM
Implementation of Standardized Early Identification and Diagnosis for Transthyretin Amyloidosis (ATTR) in High-Risk Populations
This multicenter, prospective, single-arm, interventional study will enroll about 4,000 adult patients at high risk of ATTR amyloidosis from around 50 sites in China.
- Trial name
- NCT07338942
- Testing
- implementation of standard early identification and diagnosis of ATTR
- Where
- 48 sites in China
- Volunteers
- 4,000 people
- Sponsor
- AstraZeneca
ATTR-PN
Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis
This is a Phase 3, open-label study designed to obtain additional long-term safety and efficacy data for oral tafamidis (20 mg soft gelatin capsule) administered once daily (QD).
- Trial name
- NCT00925002
- Testing
- Tafamidis
- Where
- 9 sites in United States, Argentina and 6 more
- Volunteers
- 93 people
- Sponsor
- Pfizer
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in participants with ATTR amyloidosis with cardiomyopathy.
- Trial name
- NCT04153149
- Testing
- Vutrisiran, Sterile Normal Saline (0.9% NaCl)
- Where
- 121 sites in United States, Argentina and 31 more
- Volunteers
- 655 people
- Sponsor
- Alnylam Pharmaceuticals