A Phase 1/2 Study of Linvoseltamab in Patients With Relapsed or Refractory Systemic Light Chain Amyloidosis
This study is researching an experimental drug called linvoseltamab ("study drug"). This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again. The study consists of 2 phases (Phase 1 and Phase 2): - In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2. - In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL amyloidosis. The study is looking at several other research questions, including: - How many participants treated with linvoseltamab have improvement in the abnormal proteins that cause organ problems and for how long - How many participants treated with linvoseltamab have improvement in the heart or kidney and for how long - What the right dosing regimen is for linvoseltamab - What side effects may happen from taking linvoseltamab - How much linvoseltamab is in your blood at different times - Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects)
NCT06292780 — Relapsed/Refractory Systemic Light Chain Amyloidosis
Status: Not yet recruiting
http://inclinicaltrials.com/relapsed-refractory-systemic-light-chain-amyloidosis/NCT06292780/
Phenotyping and Characterization of Danish Wild-type Transthyretin Amyloidosis Cardiomyopathy Patients: A Cross-sectional Study
Descriptive cross-sectional study on 100 consecutive ATTRwt-CM patients reflecting all NAC stages aiming primarily to investigate ATTRwt-CM patient's quality of life (QoL) measures and their relation to ATTRwt-CM severity. Secondarily aiming to investigate the possibility to measure misTTR and fragTTR in plasma and urine and to detect fragTTR in endomyocardial biopsies from ATTRwt-CM patients. To investigate whether misTTR and fragTTR levels are correlated with ATTRwt-CM severity.
NCT06291805 — Quality of Life
Status: Recruiting
http://inclinicaltrials.com/quality-of-life/NCT06291805/
Bonding Molecular Genotyping and Phenotyping to Outcome Measures in AL Amyloidosis: A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)
A prospective patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers from across Europe and a sample sharing network will be created to study mechanisms of the disease through the use of advanced molecular technologies and big data analysis tools.
NCT06205953 — AL Amyloidosis
Status: Recruiting
http://inclinicaltrials.com/al-amyloidosis/NCT06205953/
Prevalence of Cardiac Amyloidosis in Heart Failure Patients With Preserved Left Ventricular Ejection Fraction in Tunisia
Cardiac amyloidosis (CA) has recently been reported as a common cause of heart failure with preserved left ventricular ejection fraction (HFpEF), with a prevalence of 6% in elderly HFpEF patients. However, the diagnosis of CA is still challenging and requires multiple costly investigations. Regardless of the type of CA, TTR or AL, early diagnosis significantly improves prognosis. In this study, the investigators aimed to determine the prevalence of CA in Tunisian HFpEF patients and to identify clinical and ultrasound criteria predictive of CA.
NCT06201832 — Heart Failure With Preserved Ejection Fraction
Status: Recruiting
http://inclinicaltrials.com/heart-failure-with-preserved-ejection-fraction/NCT06201832/
AMYLO-SHIATSU-ACUTE-CHRONIC : EFFECTS OF SHIATSU ON SYMPTOMS AND QUALITY OF LIFE OF AMYLOIDOSIS PATIENTS
Demonstrate the beneficial impact of three targeted Shiatsu sessions versus "comfort" Shiatsu on symptoms in cardiac amyloidosis patients with severe symptoms. To demonstrate the beneficial short-term impact of a targeted SHIATSU session on neuro-cardio-vascular physiological parameters and symptoms in patients with cardiac amyloidosis compared with comfort Shiatsu and no Shiatsu. To demonstrate the beneficial impact of three targeted Shiatsu sessions versus "comfort" Shiatsu and no Shiatsu on symptoms (fatigue, sleep, pain, anxiety, depression dyspnea, digestive disorders, nausea) and quality of life in cardiac amyloidosis patients with severe symptoms. Evaluate patient satisfaction with shiatsu. Assess tolerance to shiatsu.
NCT06197165 — Cardiac Amyloidosis
Status: Not yet recruiting
http://inclinicaltrials.com/cardiac-amyloidosis/NCT06197165/
Optimize First-line Treatment for Systemic Light Chain Amyloidosis With t (11; 14)
Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%. Considering that Bcl-2 inhibitor is effective for AL amyloidosis with t(11; 14) and the median hematologic onset time of DBD is 7 days. We design a a prospective study on AL amyloidosis with t(11; 14). All patients receive DBD at the beginning. Patient will receive DBD for at least 6 cycles if achieve rapid hematologic response at day 7, while other patients will receive daratumumab, venetoclax and dexamethasone.
NCT06192979 — AL Amyloidosis
Status: Recruiting
http://inclinicaltrials.com/al-amyloidosis/NCT06192979/
Histopathological Incidence of Amyloidosis in High-Risk Patients Undergoing Cardiac Device Implantation
This single-practice prospective cohort study aims to enhance the diagnosis of cardiac amyloidosis in high-risk patients undergoing standard cardiac device implantation. By analyzing chest wall fat tissue, which is usually discarded, we aim to determine the diagnostic yield of such biopsies for amyloidosis and to develop a predictive screening model based on clinical, lab, and imaging data. The study, running from December 2023 to December 2024, expects to enroll 100 patients and may provide a new, non-invasive diagnostic avenue for this condition.
NCT06186167 — Cardiac Amyloidosis
Status: Recruiting
http://inclinicaltrials.com/cardiac-amyloidosis/NCT06186167/
Validation of Different Diagnostic Modalities in the Detection of Cardiac Amyloidosis Among Patients With "Red Flags"
The study aims to test and compare the diagnostic yield of different diagnostic modalities (speckle tracking echocardiography, CMR, serum and urine protein analysis and bone tracer scintigraphy) in the detection of cardiac amyloidosis among patients with "red flags" suspecting cardiac amyloidosis.
NCT06175858 — Cardiac Amyloidosis
Status: Not yet recruiting
http://inclinicaltrials.com/cardiac-amyloidosis/NCT06175858/
Cardiac Amyloidosis Registry of University Hospital Leipzig
This is a clinical registry of patients with cardiac amyloidosis being treated at University Hospital Leipzig. The aim of the registry is to collect detailed information about clinical events, symptoms, imaging, biomarkers, comorbidities, and treatment from routine patient management which would not be provided by randomized clinical trails.
NCT06129656 — Cardiac Amyloidosis
Status: Recruiting
http://inclinicaltrials.com/cardiac-amyloidosis/NCT06129656/
Aortic Stenosis and Cardiac Amyloidosis: A Pragmatic, Streamlined International
The dual pathology of aortic stenosis (AS) and cardiac amyloidosis (CA) is increasingly recognized. Even tough efforts have been undertaken to bring cohorts together, the largest cohort of AS-ATTR to date is <50 patients. It is the aim of the present international, multi-center registry to collect ~300 patients with AS-CA creating a big enough cohort to allow 1. thorough characterization of this condition 2. assessment of log-term clinical outcomes of AS-CA 3. assessment of effectiveness of amyloid-specific treatment on top of valve replacement
NCT06129331 — Aortic Stenosis
Status: Recruiting
http://inclinicaltrials.com/aortic-stenosis/NCT06129331/