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Cardiomyopathies clinical trials

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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: NCT06048562 Completed - Clinical trials for Hypertrophic Cardiomyopathy

Incidence of Hypertrophic Cardiomyopathy in Infants of Diabetic Mothers Attending in NICU at Assiut University Children Hospital During One Year

Start date: March 20, 2019
Phase: N/A
Study type: Interventional

To evaluate all full term infants of diabetic mother for the presence of hypertrophic cardiomyopathy who admitted in NICU at Assiut University Children Hospital and to follow up of these cases after 6 months for recovery.

NCT ID: NCT06040242 Recruiting - Clinical trials for Arrhythmogenic Right Ventricular Cardiomyopathy

Arrhythmogenic Activity During Exercise in ARVC Patients

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Current guidelines advocate that ARVC patients, typically young and active individuals with a significant history of competitive endurance sports, cease endurance training in favour of activities with low cardiac burden such as bowling and golf. Empirically, it is often suggested that heart rate during exercise should not exceed 100-120 bpm in these patients, but these guidelines are arbitrary and not scientifically based. In practice, it is estimated that up to 50% of patients do not comply with these recommendations . Adequate quantification of the arrhythmogenic burden, defined as premature ventricular beats in proportion to all heart beats in each period of time, and cardiac load (defined as stroke volume for volume load and systolic blood pressure for pressure load) experienced by ARVC patients when performing different types of physical exercise would be a first step towards designing a safe and effective intervention so that these patients can profit from an active life style. This study therefore aims to quantify and describe the arrhythmogenic burden and cardiac load experienced by patients with ARVC while performing different physical exercise over a range of intensities - all strictly within the range currently recommended by different cardiological societies.

NCT ID: NCT06039969 Recruiting - Clinical trials for Cardiac Rehabilitation

Evaluate Aerobic Exercise on Myocardial Fibrosis and Intestinal Flora in Dilated Cardiomyopathy Diagnosed First Time.

Start date: October 1, 2023
Phase:
Study type: Observational

To invegstive the Changes of Intestinal Flora and the improvements of Cardiac Fibrosis in Patients With Dilated Cardiomyopathy Diagnosed for the First Time by heart Rehabilitation

NCT ID: NCT06039072 Not yet recruiting - Clinical trials for Cardiomyopathy, Dilated

Clinical Observation of Long-term Cardiac Function Prognosis in Patients With PPCM Who Have Recovered Cardiac Function

Start date: October 10, 2023
Phase:
Study type: Observational [Patient Registry]

Peripartum cardiomyopathy (PPCM) is an idiopathic cardiomyopathy that occurs in late pregnancy and early postnatal period, which is mainly characterized by varying degrees of impaired ventricular systolic function and symptoms related to heart failure, and is a serious threat to maternal health. About 50% of patients can achieve complete recovery of cardiac function within 6 months after diagnosis with early standardized treatment, about 30%-40% of patients can have delayed recovery, and about 12.6% of patients have long-term impairment of cardiac function and poor prognosis. However, there are still controversies about whether and when to stop the drug after standardized treatment. The Chinese Society of Cardiovascular Disease of the Chinese Medical Association proposed in the Guidelines for the Diagnosis and Treatment of Dilated Cardiomyopathy in China that patients with PPCM should be considered for gradual withdrawal of the drug after at least 1 year of stabilization of cardiac structure and function recovery. And in the China Heart Failure and Diagnostic and Treatment Guidelines released in the same year, it is proposed that standardized heart failure therapy for patients with peripheral cardiomyopathy should be continued until at least 6 months after the left ventricular function has been fully recovered before gradual discontinuation of the drug. The American Heart Association's 2019 guidelines for perinatal cardiomyopathy remain skeptical about the timing of discontinuation, with some experts suggesting that the drug can be gradually discontinued 1-2 years after cardiac function has recovered, while others still recommend long-term use of the drug to avoid deterioration of cardiac function after discontinuation. At present, there is a lack of large-scale clinical studies on the effect of stopping standardized treatment on the long-term prognosis of PPCM patients, and clarifying whether PPCM patients can discontinue the drug and the timing of discontinuation is of great significance to the long-term prognosis of the patients and even to the rational allocation of the national healthcare resources as a whole.

NCT ID: NCT06034405 Recruiting - Clinical trials for Lumbar Spinal Stenosis

Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis

Start date: September 19, 2023
Phase:
Study type: Observational

Primary objective: To identify older adults with transthyretin cardiac amyloidosis (ATTR-CA) early in the course of the illness, at a time when disease modifying therapies are most effective. The specific aims of this epidemiologic investigation include: 1. To identify subjects with previous lumbar spinal stenosis (LSS) Surgery who have evidence of transthyretin (TTR) amyloid deposits in spinal specimens and could be at risk for ATTR cardiac amyloidosis. 2. To evaluate for ATTR-CA among those with localized TTR in the spinal tissue. The study will also explore the following: 1. The prevalence of amyloid in lumbar spinal stenosis specimens by Congo Red staining. 2. The prevalence of TTR deposits among subjects with amyloid as determined by mass spectrometry. 3. Evaluation of a novel artificial intelligence technique for that can identify amyloid histologically with standard H&E staining. 4. Difference in ATTR-CA prevalence between subjects with TTR and indeterminate amyloid deposits in subject's spine by myocardial uptake of technetium pyrophosphate scan (Tc99-PYP).

NCT ID: NCT06031519 Active, not recruiting - Arrhythmia Clinical Trials

Impact of Liwen Procedure in Obstructive Hypertrophic Cardiomyopathy on Arrhythmias

Start date: August 22, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the occurrence of various arrhythmias ( tachyarrhythmia and bradyarrhythmia ) during or after Percutaneous Intramyocardial Septal Radiofrequency Ablation. The main questions it aims to answer are: - To investigate the occurrence of various arrhythmias ( tachyarrhythmia and bradyarrhythmia ) during procedure and its relationship with clinical characteristics and procedural parameters - To analyze the changes of 12-lead electrocardiogram and 24-hour dynamic electrocardiogram before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation and their relationships with clinical characteristics and procedural parameters

NCT ID: NCT06031077 Completed - Clinical trials for Cardiovascular Diseases

Effectiveness and Safety of Distal Left Transradial Access in Coronary Procedures.

Start date: January 1, 2020
Phase:
Study type: Observational

To evaluate the effectiveness and safety of distal left radial (dLR) access in coronary procedures at a tertiary center in Trinidad and Tobago.

NCT ID: NCT06029452 Completed - ATTR-CM Clinical Trials

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).

Start date: September 1, 2023
Phase:
Study type: Observational

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 patients. This study will include HF patients ≥50 years old.

NCT ID: NCT06029400 Recruiting - Clinical trials for Different Cardiomyopathy and Major Cardiovascular Adverse Events

CT-based Myocardial Characterization (CTMyoC)

CTMyoC
Start date: October 12, 2020
Phase:
Study type: Observational

The identification of myocardial fibrosis in term of myocardial scar and extracellular matrix remodelling assessed respectively with the technique of Late Gadolinium Enhancement (LGE) and with the quantification of the Extracellular Volume Fraction (ECV) in Cardiac Magnetic Resonance has been demonstrated to be crucial in the diagnosis of different cardiomyopathy and to be prognosticators of major cardiovascular adverse events [1-14]. For these reason CMR represent the gold standard for the non-invasive characterization of myocardial tissue in the clinical practice. However, regardless of its indisputable clinical role, CMR has many limitations: 1) it does not allow to evaluate coronary arteries; 2) it is contraindicated in patients with cardiac devices, and in case of conditional device they may also significantly impair LGE assessability due to artefacts [19]); 2) has limited availability and it is time consuming, therefore it is difficult to perform in the acute setting also because of poor patient compliance; 3) it is not feasible in patients suffering from claustrophobia. Cardiac Computed Tomography (cCT) is the image of choice to non-invasively study coronary arteries, not assessable with CMR. Moreover the recent technological advancement has continuously increased the clinical indication to the evaluation of cardiac valve and fibrosis, with reduced acquisition time respect to CMR (few minutes vs 1 hour), radiation exposure and costs. cCT has emerging as a possible alternative to CMR in the characterization of myocardial scar and extracellular volume fraction, with the advantage of a single shot evaluation of coronary arteries and myocardial tissue remodelling (scar, diffuse fibrosis, contractility..).In particular, several studies including some from our group, have demonstrated the clinical utility of myocardial tissue characterization with cCT in different clinical settings, such as myocardial infarction [20, 21], myocarditis [22], hypertrophic cardiomyopathy (HCM) [23], heart failure [24], ventricular tachycardia [25], and sarcoidosis [26]. Despite the interesting results, all these previous studies are limited on highly selected and small sample size. Moreover, any large study with long term follow-up is available in the setting of tissue characterization (myocardial scar and ECV) in cCT also as well as combined with a multiparametric approach (cardiac chamber morphofuntionality,contractility-strain, valve calcification, geometry, coronary atherosclerosis, myocardial perfusion, myocardial strain and texture) and no data are available about its prognostic impact. Aim of the study is to evaluate the potential of cCT in tissue characterization (myocardial scar and ECV) alone and associate to other CT imaging biomarker on a large population of patient clinically candidate to cardiac CT.