NCT05167799|Unknown
Cardiac Contractility Modulation Therapy in Amyloid Cardiomyopathy Patients With Heart Failure
AMY-CCM
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AMY-CCM
Sponsor study identifier
observational
25
1 country
1
Study Start
May 13, 2021
Actual (reported)Primary Completion
December 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 13, 2021
Actual (reported)December 7, 2021
Actual (reported)December 22, 2021
Actual (reported)December 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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.
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)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Ospedale Mazzoni
Ascoli Piceno, Marche (AP), 63100, Italy
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.
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.
Procolo Marchese, MD
Ospedale Mazzoni (Ascoli Piceno)
First Submitted
December 7, 2021
First Posted
December 22, 2021
Study Start
May 13, 2021
Actual (reported)Primary Completion
December 1, 2023
Estimated (date passed)Cardiac Contractility Modulation in Chagas Heart Disease
Contact the study team to confirm eligibility.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 22, 2021
Record last verified: 2021-12
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