Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.

Launched by SCIENTIFIC INSTITUTE SAN RAFFAELE · Sep 18, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding and improving the diagnosis and treatment of various types of non-ischemic cardiomyopathies (NICM), which are heart conditions not caused by blocked arteries. The study aims to identify different forms of NICM, such as dilated cardiomyopathy and arrhythmogenic cardiomyopathy, and how they may lead to serious heart rhythm problems or inflammation. Researchers will categorize patients into two groups: those experiencing heart rhythm issues and those with other heart-related symptoms. By studying these groups, the trial seeks to find the best ways to manage these conditions and improve patient outcomes.

To participate in the trial, individuals must be diagnosed or suspected of having NICM and provide written consent. This includes patients with various forms of NICM, such as genetic and inflammatory types. Participants can expect to undergo evaluations to determine the presence of heart rhythm issues or inflammation. The trial is currently recruiting individuals of all genders, ages 65 to 74, and aims to gather valuable information that could enhance diagnosis and treatment for those affected by these heart conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written informed consent. For pediatric patients, consent will be obtained by parents, according to the laws applicable in each of the participating countries.
• • Clinical suspicion of NICM, and/or proven diagnosis of any NICM and/or genotype consistent with any NICM.
• • NICMs will include but not limit to: DCM, HCM, RCM, ACM, inflammatory, infiltrative, dysmetabolic, mitochondrial, toxic, neuromuscular, rheumatologic/autoimmune cardiomyopathies, channelopathies with structural substrates, LVNC, PPCM, AMVP, AFD, athlete's heart, undefined and overlap cardiomyopathies. Additional diseases of the NICM spectrum will be included in parallel with the advance of the current knowledge.
• Exclusion Criteria:
• • Absent informed consent.
• • Proven diagnosis of cardiac disease alternative to NICM.
• • Lack of diagnostic workup suitable for diagnosing NICM, detecting arrhythmias, or detecting M-Infl.
• • For patients retrospectively enrolled: lack of active status of follow-up at the enrolling center.