Cardiac Contractility Modulation Therapy in Amyloid Cardiomyopathy Patients With Heart Failure

NCT05167799 | Unknown

• 1 other identifier: AMYCCM190421
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this observational registry is to evaluate the efficacy of CCM in patients with heart failure with mid-range or reduced EF and diagnosis of TTR amyloidosis. The efficacy will be evaluated in terms of composite of occurrence of heart failure-related hospitalizations and/or acute intravenous interventions (IVI) at 12-month follow up compared to those reported 12 months before CCM implantation. Among the secondary endpoints, clinical functional status, quality of life, drug changes and Echocardiographic parameters will be evaluated and compared from baseline to follow up.

Conditions

Amyloidosis Cardiac; Heart Failure

Keywords

Cardiac Amyloidosis; Heart Failure; Cardiac Contractility Modulation; CCM

Outcome Measures

Primary Outcomes (1)

• Composite of occurrence of hospitalizations due to worsening of heart failure and/or acute intravenous administrations of diuretics or inotropic drugs over the 12 months after entry into the registry.

  The occurrence of any of the events mentioned (worsening of heart failure or intravenous intervention) involves reaching the endpoint

  12-month

Secondary Outcomes (9)

• Occurrence of clinical need to increase oral dose of diuretic drug and/or to add another diuretic drug class

  12-month

• Occurrence of oral dose diuretic drug reduction

  12-month

• NYHA class

  12-month

• Distance walked at the 6-minute walking test

  12-month

• Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) score

  12-month

Study Arms (1)

Cardiac Amyloidosis patients

Patients with 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. Already implanted with ICD or PM if needed, fullfilling the indication for CCM implantation.

Device: Cardiac Contractility Modulation (CCM)

Interventions

Cardiac Contractility Modulation (CCM) DEVICE

Patients will be implanted with CCM device according to indications, to improve Heart Failure symptoms and then enrolled in the Registry if they fullfil Inclusion and Exclusion Criteria (First of all if they are diagnosed with TTR Amyloidosis)

Cardiac Amyloidosis patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This Registry includes patients with chronic, symptomatic heart failure with moderately-to-severely reduced left ventricular systolic function despite optimal pharmacological and electrical therapy, who have been diagnosed with TTR Cardiac Amyloidosis. The clinical trial study (prospective registry) will be conducted in accordance with the protocol, with the Helsinki Declaration and with the favorable opinion of the local Ethics Committee of the participating Centers.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale C & G Mazzoni: lead

Study Sites (1)

Ospedale Mazzoni

Ascoli Piceno, Marche (AP), 63100, Italy

RECRUITING

Related Publications (5)

• Shi J, Guan J, Jiang B, Brenner DA, Del Monte F, Ward JE, Connors LH, Sawyer DB, Semigran MJ, Macgillivray TE, Seldin DC, Falk R, Liao R. Amyloidogenic light chains induce cardiomyocyte contractile dysfunction and apoptosis via a non-canonical p38alpha MAPK pathway. Proc Natl Acad Sci U S A. 2010 Mar 2;107(9):4188-93. doi: 10.1073/pnas.0912263107. Epub 2010 Feb 11.

  PMID: 20150510 RESULT

• Brenner DA, Jain M, Pimentel DR, Wang B, Connors LH, Skinner M, Apstein CS, Liao R. Human amyloidogenic light chains directly impair cardiomyocyte function through an increase in cellular oxidant stress. Circ Res. 2004 Apr 30;94(8):1008-10. doi: 10.1161/01.RES.0000126569.75419.74. Epub 2004 Mar 25.

  PMID: 15044325 RESULT

• Kristen AV, Dengler TJ, Hegenbart U, Schonland SO, Goldschmidt H, Sack FU, Voss F, Becker R, Katus HA, Bauer A. Prophylactic implantation of cardioverter-defibrillator in patients with severe cardiac amyloidosis and high risk for sudden cardiac death. Heart Rhythm. 2008 Feb;5(2):235-40. doi: 10.1016/j.hrthm.2007.10.016. Epub 2007 Oct 9.

  PMID: 18242546 RESULT

• Abraham WT, Kuck KH, Goldsmith RL, Lindenfeld J, Reddy VY, Carson PE, Mann DL, Saville B, Parise H, Chan R, Wiegn P, Hastings JL, Kaplan AJ, Edelmann F, Luthje L, Kahwash R, Tomassoni GF, Gutterman DD, Stagg A, Burkhoff D, Hasenfuss G. A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation. JACC Heart Fail. 2018 Oct;6(10):874-883. doi: 10.1016/j.jchf.2018.04.010. Epub 2018 May 10.

  PMID: 29754812 RESULT

• Anker SD, Borggrefe M, Neuser H, Ohlow MA, Roger S, Goette A, Remppis BA, Kuck KH, Najarian KB, Gutterman DD, Rousso B, Burkhoff D, Hasenfuss G. Cardiac contractility modulation improves long-term survival and hospitalizations in heart failure with reduced ejection fraction. Eur J Heart Fail. 2019 Sep;21(9):1103-1113. doi: 10.1002/ejhf.1374. Epub 2019 Jan 16.

  PMID: 30652394 RESULT

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Heart Failure

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies; Heart Diseases; Cardiovascular Diseases

Study Officials

• Procolo Marchese, MD

  Ospedale Mazzoni (Ascoli Piceno)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Procolo Marchese, MD

CONTACT

+393921133283; procolo.marchese@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 22, 2021
• Study Start: May 13, 2021
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: December 22, 2021

Record last verified: 2021-12

Locations

IT (1)