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Amyloidosis clinical trials

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NCT ID: NCT05793320 Recruiting - Amyloidosis Clinical Trials

Carpal Tunnel Release With Risk Factors for Amyloidosis

Start date: August 3, 2023
Phase: N/A
Study type: Interventional

Bilateral carpal tunnel syndrome has been demonstrated in previous literature to be a warning sign for potential amyloidosis. One study has been performed in which patients with bilateral carpal tunnel syndrome underwent tissue biopsy (either tendon sheath or transverse carpal ligament) at the time of carpal tunnel release to determine the strength of association as well as most common subtypes. However, no study has been done demonstrating whether or not patients with amyloid-positive carpal tunnel biopsy would benefit from an early referral to cardiology for a work-up of potential cardiac amyloidosis. In our study, patients with bilateral carpal tunnel symptoms who are indicated for carpal tunnel release would be identified in clinic and undergo biopsy for congo red staining at the time of surgery. All patients with positive biopsy results would be referred to cardiology. Outcomes would include the rate of amyloid positivity, common subtypes, and echocardiographic findings after cardiac referral.

NCT ID: NCT05776940 Not yet recruiting - Clinical trials for Immunoglobulin Light-chain Amyloidosis

Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis

Start date: March 31, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this clinical trial is to evaluate whether specific probiotic can reduce gastrointestinal symptoms and improves therapeutic response, on a background of Bortezomib+dexamethasone or Bortezomib+dexamethasone combined with daratumumab therapy, for naive AL amyloidosis patients.

NCT ID: NCT05776212 Recruiting - ATTR-CM Clinical Trials

Quantitative-imaging in Cardiac Transthyretin Amyloidosis

I-CARE
Start date: August 25, 2021
Phase:
Study type: Observational

Transthyretin amyloid cardiomyopathy (ATTR-CM), is a heart muscle disease that's stops the heart muscle working properly. With an ageing population, it is increasingly common but untreated, it has a poor prognosis. Several novel expensive treatments have become available, although we do not understand exactly how they work and why some patients respond, and others do not. The challenge is to develop better methods for monitoring the effects of these treatments, maximizing their benefits and cost-effectiveness. In I-CARE we aim to bring a new imaging technique, named 18F-fluoride PET, to the clinic and thereby improve the care of patients with ATTR-CM. Hypotheses: 1. A delayed imaging protocol and state-of-the-art PET motion correction will optimise 18F-fluoride imaging in ATTR-CM and provide a clear threshold in myocardial TBR values for the diagnosis of ATTR-CM. 2. Optimised 18F-fluoride PET will provide a quantitative marker of the ATTR-CM burden that will allow disease progression and treatment response to be tracked. 3. Myocardial 18F-fluoride TBR values will reduce in patients responding to tafamidis treatment and increase in non-responders and patients not receiving therapy

NCT ID: NCT05772091 Recruiting - Clinical trials for Transthyretin Cardiac Amyloidosis

Prognostic Value of Echocardiographic Parameters Based on Machine Learning Approach

ATTR-AI
Start date: September 29, 2023
Phase:
Study type: Observational

Transthyretin cardiac amyloidosis is an increasingly recognized cause of heart failure with preserved ejection fraction. Its diagnosis is currently based on a non-invasive method including biology and imaging. Still currently incurable, the evolution of this pathology is burdened by numerous comorbidities, including iterative hospitalizations for heart failure leading to death. The Machine Learning approach has already shown its efficiency in terms of diagnosis but its prognostic approach has not yet been studied.

NCT ID: NCT05760287 Recruiting - Cardiac Amyloidosis Clinical Trials

Echocardiographic Characterization of Cardiac Amyloidosis: an Observational Study

Echo-AMY
Start date: December 9, 2022
Phase:
Study type: Observational

This is a mono-center observational ambispective study in which patients with cardiac amyloidosis evaluated at our institution will be enrolled. The primary aim is to investigate echocardiographic findings, particularly using advanced echocardiographic techniques, such as two- and three-dimensional speckle-tracking analysis, that may be helpful in the differential diagnosis between cardiac amyloidosis and other cardiomyopathies with hypertrophic phenotype. Secondary aims are: 1) to evaluate the reversibility of myocardial damage, assessed by echocardiography, in response to a newly available specific treatment for patients with transthyretin-related cardiac amyloidosis (tafamidis ) and its correlation with the clinical response 2) to investigate potential novel echocardiographic predictors of adverse cardiovascular outcomes.

NCT ID: NCT05758493 Recruiting - Amyloidosis Clinical Trials

Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis

Start date: January 10, 2023
Phase: Phase 2
Study type: Interventional

This is a single center prospective study evaluating 124I-evuzumitide in patients with systemic amyloidosis. The purpose of this study is to 1)identify and characterize the distribution and uptake of 124I-evuzumitide in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) and 2) Correlate the uptake with the structure and function of different organs, including the heart. To achieve these goals, eligible patients will undergo primarily hybrid positron emission tomography and magnetic resonance imaging (PET/MRI). In a subgroup of patients who are unable to undergo PET/MR, computed tomography will be used instead of MRI (i.e. PET/CT). In a subgroup of patients, repeat imaging with the same modality will be done at a interval of 6-12 months. Clinically available data (demographics, phenotype, imaging, laboratory) will also be collected to characterize the disease in each patient.

NCT ID: NCT05754099 Recruiting - Amyloidosis Clinical Trials

Identification of Clinically Significant Markers of ATTRv in Pre-symptomatic Mutation Carriers.

Start date: March 1, 2022
Phase:
Study type: Observational

The objective of this prospective observational study is to periodically monitor pre-symptomatic subjects carrying a mutation of Transthyretin (TTR), identified in the context of a family screening of affected proband, through instrumental methods and clinical scales in order to identify the first signs of clinically significant organ involvement by the disease. Healthy asymptomatic carriers will be subjected to regular monitoring through clinical evaluations and instrumental investigations defined by the consensus group (Conceicao et al.) in order to validate the criteria defined by this group to define the onset of the disease. A subgroup of carriers with scales and instrumental tests negative for damage to the peripheral nervous system or cardiac, but with subjective symptoms compatible with the disease, will be subjected to further instrumental tests not indicated by consent.

NCT ID: NCT05738005 Recruiting - Amyloidosis Clinical Trials

Dietary Reporting In The Amyloidoses

DRITA
Start date: March 2, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about malnutrition and weight loss in patients with Amyloidosis. The main question it aims to answer is: Is it feasible to use a low-cost nutrition-based application (apps) for use on a smartphone to obtain detailed information on caloric intake in Amyloidosis patients Participants will be asked to: - Download the MyFitnessPal application on their smartphone and view an online tutorial - After a week of practice, from weeks 2-9, participants will enter daily dietary intake as well as daily herbal/alternative supplement intake into the MyFitnessPal application on their smartphone. - complete a questionnaire prior to starting the application, after week 2 and at week 10 after starting the application

NCT ID: NCT05734378 Recruiting - Clinical trials for Cerebral Amyloid Angiopathy

Prognosis of Cerebral Small Vessel Disease

PRO-SVD
Start date: December 1, 2020
Phase:
Study type: Observational [Patient Registry]

Prognosis of small vessel disease (SVD) depends on the underlying type of SVD and index manifestation. The aim of this prospective, observational cohort study is to determine the risk of different outcome events among patients with SVD according to the type of index presentation.

NCT ID: NCT05718401 Enrolling by invitation - Multiple Myeloma Clinical Trials

The Diagnostic Pattern and Prognosis of Multiple Myeloma Patients With Myocardial Amyloidosis Were Evaluated by NMR Based Metabolomics

Start date: November 1, 2022
Phase:
Study type: Observational

In this clinical study, a single-center retrospective cohort study was used to explore the clinical characteristics and risk factors of patients with multiple myeloma myocardial amyloidosis. An exploratory study was conducted to compare the effects of various sublayer factors (M protein, electrocardiogram, echocardiography, CD138, chromosome abnormalities, etc.) on patients' survival. On this basis, a hierarchical diagnostic model (1-2-3-4) for patients with multiple myeloma complicated with myocardial amyloidosis was established based on the phenoomics of NMR and mass spectrometry, and the prognosis was evaluated simultaneously, in order to create an early, non-invasive, sensitive and quantitative diagnostic model for multiple myeloma complicated with myocardial amyloidosis, and lay a foundation for the early application of effective treatment.