Cardiac Contractility Modulation Therapy in Amyloid Cardiomyopathy Patients With Heart Failure
Launched by OSPEDALE C & G MAZZONI · Dec 21, 2021
Trial Information
Current as of June 09, 2025
Unknown status
Keywords
ClinConnect Summary
Amyloidosis represents a group of human degenerative diseases characterized by the deposition of aggregates of abnormally folded proteins in single or multi-organs. Cardiac amyloidosis is primarily associated with the systemic production and release of a number of amyloidogenic proteins, notably immunoglobulin light chain proteins (also known as amyloid light chain or AL) or transthyretin proteins (TTR). Notably, although myocardial dysfunction is generally understood as a result of infiltration by extracellular amyloid deposits, there is experimental evidence of direct cytotoxic effect, po...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age 18 years or older
- • Male or a nonpregnant female
- • All of the following: Established diagnosis of amyloid TTR Cardiomyopathy; baseline ejection fraction ≥25% and ≤45%; at least one hospitalization due to worsening heart failure over the year before entry into the registry.
- • ICD if indicated
- • PM if indicated
- • Willing and able to return for all follow-up visits
- Exclusion Criteria:
- • AL amyloid cardiomyopathy
- • Subjects who have a potentially correctible cause of heart failure (eg, Ischemic or valvular or congenital heart disease).
- • Scheduled for CABG or PCI or has undergone a CABG within 90 d or PCI within 30 d.
- • Myocardial infarction within 90 days
- • Mechanical tricuspid valve
- • Prior heart transplant
- • Chronic haemodialysis
- • Familial TTR amyloidotic cardiomyopathy with significant polyneuropathy potentially eligible for Patirisan or Inotersen17
- • Unable to provide informed consent
About Ospedale C & G Mazzoni
Ospedale C & G Mazzoni is a renowned healthcare institution dedicated to advancing medical knowledge and improving patient outcomes through rigorous clinical research. With a commitment to excellence in patient care and innovative treatment approaches, the hospital actively sponsors and conducts clinical trials across various medical disciplines. By collaborating with leading researchers and healthcare professionals, Ospedale C & G Mazzoni aims to contribute to the development of new therapies and enhance the understanding of complex health conditions, ensuring the highest standards of clinical integrity and ethical practices in all its research endeavors.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ascoli Piceno, Marche (Ap), Italy
Patients applied
Trial Officials
Procolo Marchese, MD
Principal Investigator
Ospedale Mazzoni (Ascoli Piceno)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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