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Search / Trial NCT05167799

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

Cardiac Amyloidosis Heart Failure Cardiac Contractility Modulation Ccm

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.

Locations

Ascoli Piceno, Marche (Ap), Italy

Patients applied

0 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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