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Amyloid Cardiomyopathy clinical trials

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NCT ID: NCT06328075 Recruiting - Clinical trials for Transthyretin Amyloid Cardiomyopathy

Artificial Intelligence to Assist the Echocardiographic Identification of Transthyretin Cardiac Amyloidosis

AI-ATTR-ECHO
Start date: January 1, 2022
Phase:
Study type: Observational

The goal of this study is to develop an algorithm using artificial intelligence (AI) to assist identification of potential ATTR-CM cases using routine transthoracic echocardiography. The main questions it aims to answer are: - is the algorithm able to diagnose ATTR-CM - is the algorithm able to diagnose different types of ATTR-CM (ATTRv, ATTRwt) This is a non interventional study. Participant' echocardiographies will be, after deidentification, used to train, valid and test the algorithm.

NCT ID: NCT06261216 Recruiting - Clinical trials for Amyloid Cardiomyopathy

Association Between Lifetime Physical Activity and Exercise and the Development of Wild-type Transthyretin Amyloid Cardiomyopathy

Start date: February 2024
Phase:
Study type: Observational

The aim of this study is to investigate the association between increased lifetime physical activity and the development of wild-type transthyretin amyloid cardiomyopathy.

NCT ID: NCT06048601 Recruiting - Clinical trials for Amyloid Cardiomyopathy

18F-florbetaben PET-CT to Non-invasively Diagnose Cardiac AL Amyloidosis

PETAL
Start date: January 26, 2023
Phase: N/A
Study type: Interventional

Amyloidoses are systemic or acquired disorders characterized by the deposition in the extracellular spaces of amyloid fibers formed by proteins codified by mutated genes or non-mutated but misfolded proteins. Cardiac involvement in amyloidosis is an important determinant of the clinical presentation and can be found in patients with amyloid light-chain (AL) or transthyretin (ATTR) amyloidosis, the latter due to the deposition of normal proteins (formerly known as senile amyloidosis) or mutated proteins. Cardiac amyloidosis (CA) has a poor prognosis that further worsens if the diagnosis and treatment are delayed. Nuclear medicine techniques have emerged as important tools for the diagnosis and characterization of CA. It has been recently demonstrated that cardiac uptake of bone tracers allows to identify the deposition of transthyretin in the heart, while it is not useful for the diagnosis of AL-CA, which currently requires the histological demonstration of amyloid fibers in a tissue sample taken with invasive procedures such as an endomyocardial biopsy. Recently, some PET tracers developed to identify beta-amyloid deposits in the brain proved able to detect an uptake even in the heart; nonetheless their possible use to diagnose CA is still debated. One of those tracers is florbetaben labelled with 18F, which displays a high binding affinity with beta-amyloid in the brain, while the experience on its use to identify extracranial amyloid deposits is still limited. Three studies have reported a cardiac uptake of 18F-florbetaben in AL or ATTR amyloidosis. Tracer uptake could be detected starting from 15 minutes after tracer administration. In a case series of 60 patients (20 with AL-CA, 20 with ATTR-CA and 20 with CA suspected but excluded) we demonstrated that the evidence of a myocardial uptake in a late acquisition can effectively discriminate AL- from ATTR-CA or other conditions. Indeed, patients with AL-CA displayed an intense and persistent myocardial uptake in static acquisitions at all time points, while patients with ATTR-CA and those without CA displayed a rapid reduction of the uptake after the early acquisition. This study aims to compare the performance of PET/CT with 18F-florbetaben to diagnose AL-CA compared with the current diagnostic standard, which requires a tissue biopsy. Primary objective: To define the agreement (with its 95% confidence interval) between two diagnostic approaches to the diagnosis of AL-CA in patients with a monoclonal protein: the traditional invasive approach and a non-invasive approach using the visual assessment of 18F-florbetaben PET/TC. Secondary objectives: - To define the diagnostic performance of PET/CT with 18F-florbetaben (visual evaluation) in terms of sensitivity, specificity, positive and negative predictive value; - To define cut-offs from myocardial uptake quantification to confirm or discard AL-CA among patients with suspected CA and a monoclonal protein, compared to the standard diagnostic algorithm, from quantitative uptake values; - To assess the changes in the degree of myocardial 18F-florbetaben uptake over 12 months in patients with AL-CA; - To assess the safety and tolerability of PET/CT with 18F-florbetaben in patients evaluated for suspected CA.

NCT ID: NCT05797857 Recruiting - Clinical trials for Amyloid Cardiomyopathy

Exercise Training in Transthyretin Cardiac Amyloidosis

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Transthyretin cardiac amyloidosis causes debilitating heart failure in older adults. The proposed research will develop a personalized exercise training program to improve functional capacity in patients on optimal treatment for transthyretin cardiac amyloidosis. This is a vital next step to improve functional capacity and quality of life of people suffering from transthyretin cardiac amyloidosis.

NCT ID: NCT05795400 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Administration of the SGLT-2 Inhibitor Dapagliflozin in the Patients With Amyloid Cardiomyopathy

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Efficacy and safety of early administration of the SGLT-2 inhibitor dapagliflozin will be evaluated in patients with HF, regardless of LVEF, due to amyloid cardiomyopathy.

NCT ID: NCT05699044 Recruiting - Clinical trials for Amyloid Cardiomyopathy

Screening of ATTRwt in Patient With Advanced AV-Block Undergoing Pacemaker Implantation

ATTRAB
Start date: October 1, 2022
Phase:
Study type: Observational

The investigators will nationally investigate the prevalence of Transthyretin Amyloidosis wildtype (ATTRwt) in patients of ≥ 65 years with left ventricular hypertrophy who present with high degree atrioventricular block (AV-block) and are admitted for pacemaker implantation. The investigators aim to characterize the group of patients with positive screening of ATTR and compare the ATTRwt disease stage at time of diagnosis for patients identified with ATTR at screening with a control group of routinely clinically diagnosed ATTRwt patients.

NCT ID: NCT05452850 Active, not recruiting - Clinical trials for Congestive Heart Failure

Longitudinal Changes in Left and Right Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis

Start date: August 11, 2022
Phase:
Study type: Observational

The purpose of this study to assess the longitudinal changes in left and right ventricular global strain after chemotherapeutic strategies in cardiac light chain amyloidosis.

NCT ID: NCT05448716 Active, not recruiting - Clinical trials for Congestive Heart Failure

Left Atrial Strain and Supraventricular Arrhythmia Burden in Cardiac Light Chain Amyloidosis Following Chemotherapy

Start date: August 10, 2022
Phase:
Study type: Observational

The purpose of this study to assess the longitudinal changes in left atrial strain and supraventricular arrhythmia burden after chemotherapeutic strategies in cardiac light chain amyloidosis.

NCT ID: NCT05103943 Recruiting - Clinical trials for Amyloid Cardiomyopathy

Amyloidosis TTR Flow Reserve Evaluation

AMYTRE
Start date: February 24, 2022
Phase: N/A
Study type: Interventional

Anginal symptoms and signs of ischemia have been reported in some patients with cardiac amyloidosis (TTR) without obstructive epicardial coronary artery disease (CAD). It was found that coronary microvascular dysfunction was highly prevalent in subjects with cardiac amyloidosis, even in the absence of epicardial CAD. The investigators found lower stress and rest myocardial blood flow (MBF) and lower myocardial flow reserve (MFR) in their cardiac PET (Positron emission tomography) study (13N), including 21 patients. The advances in SPECT technology including cadmium zinc telluride (CZT) detectors allow to evaluate the MBF and MFR estimation by SPECT as shown in both experimental animal models and also in clinical studies with comparison to PET. SPECT is more widely available than cardiac PET. Thus, the investigators would like: 1. to confirm the results of Dorbala et al using SPECT, and 2. to go further with evaluation of the effect of Tafamidis on microvascular dysfunction.

NCT ID: NCT04776824 Recruiting - Clinical trials for Amyloid Cardiomyopathy

Swiss Cardiac Amyloidosis REgistry (Swiss-CARE)

B-CARE
Start date: February 22, 2001
Phase:
Study type: Observational [Patient Registry]

Cardiac transthyretin amyloidosis (ATTR), caused by ventricular depositions of misfolded transthyretin, results in an infiltrative cardiomyopathy, progressing from pronounced myocardial wall thickening, diastolic and systolic dysfunction to the development of terminal heart failure. Recently, treatment options for TTR amyloidosis have become available. However costs for therapy are enormous and previous trials were not able to differentiate between patients that might benefit from treatment and those without a need for treatment. the investigators study aims to determine markers, as assessed by cardiac magnet resonance imaging (CMR) feature tracking (FT) and T1- and T2- mapping, that might reliably indicate disease severity and could help to identify patients that might benefit from (ongoing) TTR stabilization treatment.