Screening Algorithm for Early Detection of Occult Cardiac Amyloidosis
NCT ID: NCT05693376
Last Updated: 2024-08-20
Study Results
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Basic Information
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COMPLETED
85 participants
OBSERVATIONAL
2020-08-05
2023-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Intervention group
Subjects who meet the following inclusion criteria: 1) Severe aortic stenosis. 2) Age \> 65 years for male and \>70 years for female. 3) Increased left ventricular wall thickness ≥14 mm. 4) Blood pressure ≤ 140/90 mmHg and at least 1 major or ≥ 2 minor criteria. Major criteria: a) Carpal tunnel syndrom; b) Non-traumatic rupture of the biceps tendon; c) NT-proBNP \> 1000 pg/ml; d) hs Troponin value above the 99th percentile without dynamic changes (≤ 20%). Minor criteria: a) Diastolic dysfunction (at least grade 2, E' \< 10 cm/s); b) Sinus bradycardia/AV block/pacemaker; c) Atrial fibrillation.
No interventions assigned to this group
Control group
Subjects who meet the following inclusion criteria: 1) Severe aortic stenosis. 2) Age \> 65 years for male and \>70 years for female. 3) Increased left ventricular wall thickness ≥14 mm. 4) Blood pressure ≤ 140/90 mmHg.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Major criteria:
1. Carpal tunnel syndrom
2. Non-traumatic rupture of the biceps tendon
3. NT-proBNP \> 1000 pg/ml
4. hs Troponin value above the 99th percentile without dynamic changes (≤ 20%)
Minor criteria:
1. Diastolic dysfunction (at least grade 2, E' \< 10 cm/s)
2. Sinus bradycardia/AV block/pacemaker
3. Atrial fibrillation
Exclusion Criteria
* Unable to provide written informed consent
* Refusal to provide written informed consent
* Contraindications for study investigations
18 Years
ALL
Yes
Sponsors
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University Hospital, Essen
OTHER
Responsible Party
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Maria Papathanasiou
Principal Investigator, Cardiologist
Principal Investigators
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Aiste Monika Jakstaite, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Essen
Locations
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University Hospital Essen
Essen, North Rhine-Westphalia, Germany
Countries
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References
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Maurer MS, Elliott P, Comenzo R, Semigran M, Rapezzi C. Addressing Common Questions Encountered in the Diagnosis and Management of Cardiac Amyloidosis. Circulation. 2017 Apr 4;135(14):1357-1377. doi: 10.1161/CIRCULATIONAHA.116.024438.
Gonzalez-Lopez E, Gallego-Delgado M, Guzzo-Merello G, de Haro-Del Moral FJ, Cobo-Marcos M, Robles C, Bornstein B, Salas C, Lara-Pezzi E, Alonso-Pulpon L, Garcia-Pavia P. Wild-type transthyretin amyloidosis as a cause of heart failure with preserved ejection fraction. Eur Heart J. 2015 Oct 7;36(38):2585-94. doi: 10.1093/eurheartj/ehv338. Epub 2015 Jul 28.
Fajardo J, Cummings A, Brown E, Cuomo K, Rhodes P, Woodbury S, Gilotra N, Russell S, Judge D. Clinical pathway to screen for cardiac amyloidosis in heart failure with preserved ejection fraction. Amyloid. 2019;26(sup1):166-167. doi: 10.1080/13506129.2019.1583178. No abstract available.
Mohammed SF, Mirzoyev SA, Edwards WD, Dogan A, Grogan DR, Dunlay SM, Roger VL, Gertz MA, Dispenzieri A, Zeldenrust SR, Redfield MM. Left ventricular amyloid deposition in patients with heart failure and preserved ejection fraction. JACC Heart Fail. 2014 Apr;2(2):113-22. doi: 10.1016/j.jchf.2013.11.004.
Longhi S, Lorenzini M, Gagliardi C, Milandri A, Marzocchi A, Marrozzini C, Saia F, Ortolani P, Biagini E, Guidalotti PL, Leone O, Rapezzi C. Coexistence of Degenerative Aortic Stenosis and Wild-Type Transthyretin-Related Cardiac Amyloidosis. JACC Cardiovasc Imaging. 2016 Mar;9(3):325-7. doi: 10.1016/j.jcmg.2015.04.012. Epub 2015 Jul 15. No abstract available.
Treibel TA, Fontana M, Gilbertson JA, Castelletti S, White SK, Scully PR, Roberts N, Hutt DF, Rowczenio DM, Whelan CJ, Ashworth MA, Gillmore JD, Hawkins PN, Moon JC. Occult Transthyretin Cardiac Amyloid in Severe Calcific Aortic Stenosis: Prevalence and Prognosis in Patients Undergoing Surgical Aortic Valve Replacement. Circ Cardiovasc Imaging. 2016 Aug;9(8):e005066. doi: 10.1161/CIRCIMAGING.116.005066.
Castano A, Narotsky DL, Hamid N, Khalique OK, Morgenstern R, DeLuca A, Rubin J, Chiuzan C, Nazif T, Vahl T, George I, Kodali S, Leon MB, Hahn R, Bokhari S, Maurer MS. Unveiling transthyretin cardiac amyloidosis and its predictors among elderly patients with severe aortic stenosis undergoing transcatheter aortic valve replacement. Eur Heart J. 2017 Oct 7;38(38):2879-2887. doi: 10.1093/eurheartj/ehx350.
Cornwell GG 3rd, Murdoch WL, Kyle RA, Westermark P, Pitkanen P. Frequency and distribution of senile cardiovascular amyloid. A clinicopathologic correlation. Am J Med. 1983 Oct;75(4):618-23. doi: 10.1016/0002-9343(83)90443-6.
Tanskanen M, Peuralinna T, Polvikoski T, Notkola IL, Sulkava R, Hardy J, Singleton A, Kiuru-Enari S, Paetau A, Tienari PJ, Myllykangas L. Senile systemic amyloidosis affects 25% of the very aged and associates with genetic variation in alpha2-macroglobulin and tau: a population-based autopsy study. Ann Med. 2008;40(3):232-9. doi: 10.1080/07853890701842988.
Lee MH, Lee SP, Kim YJ, Sohn DW. Incidence, diagnosis and prognosis of cardiac amyloidosis. Korean Circ J. 2013 Nov;43(11):752-60. doi: 10.4070/kcj.2013.43.11.752. Epub 2013 Nov 30.
Desport E, Bridoux F, Sirac C, Delbes S, Bender S, Fernandez B, Quellard N, Lacombe C, Goujon JM, Lavergne D, Abraham J, Touchard G, Fermand JP, Jaccard A; Centre national de reference pour l'amylose AL et les autres maladies par depots d'immunoglobulines monoclonales. Al amyloidosis. Orphanet J Rare Dis. 2012 Aug 21;7:54. doi: 10.1186/1750-1172-7-54.
Maurer MS, Schwartz JH, Gundapaneni B, Elliott PM, Merlini G, Waddington-Cruz M, Kristen AV, Grogan M, Witteles R, Damy T, Drachman BM, Shah SJ, Hanna M, Judge DP, Barsdorf AI, Huber P, Patterson TA, Riley S, Schumacher J, Stewart M, Sultan MB, Rapezzi C; ATTR-ACT Study Investigators. Tafamidis Treatment for Patients with Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2018 Sep 13;379(11):1007-1016. doi: 10.1056/NEJMoa1805689. Epub 2018 Aug 27.
Solomon SD, Adams D, Kristen A, Grogan M, Gonzalez-Duarte A, Maurer MS, Merlini G, Damy T, Slama MS, Brannagan TH 3rd, Dispenzieri A, Berk JL, Shah AM, Garg P, Vaishnaw A, Karsten V, Chen J, Gollob J, Vest J, Suhr O. Effects of Patisiran, an RNA Interference Therapeutic, on Cardiac Parameters in Patients With Hereditary Transthyretin-Mediated Amyloidosis. Circulation. 2019 Jan 22;139(4):431-443. doi: 10.1161/CIRCULATIONAHA.118.035831.
Witteles RM, Bokhari S, Damy T, Elliott PM, Falk RH, Fine NM, Gospodinova M, Obici L, Rapezzi C, Garcia-Pavia P. Screening for Transthyretin Amyloid Cardiomyopathy in Everyday Practice. JACC Heart Fail. 2019 Aug;7(8):709-716. doi: 10.1016/j.jchf.2019.04.010. Epub 2019 Jul 10.
Oerlemans MIFJ, Rutten KHG, Minnema MC, Raymakers RAP, Asselbergs FW, de Jonge N. Cardiac amyloidosis: the need for early diagnosis. Neth Heart J. 2019 Nov;27(11):525-536. doi: 10.1007/s12471-019-1299-1.
Geller HI, Singh A, Alexander KM, Mirto TM, Falk RH. Association Between Ruptured Distal Biceps Tendon and Wild-Type Transthyretin Cardiac Amyloidosis. JAMA. 2017 Sep 12;318(10):962-963. doi: 10.1001/jama.2017.9236.
Damy T, Costes B, Hagege AA, Donal E, Eicher JC, Slama M, Guellich A, Rappeneau S, Gueffet JP, Logeart D, Plante-Bordeneuve V, Bouvaist H, Huttin O, Mulak G, Dubois-Rande JL, Goossens M, Canoui-Poitrine F, Buxbaum JN. Prevalence and clinical phenotype of hereditary transthyretin amyloid cardiomyopathy in patients with increased left ventricular wall thickness. Eur Heart J. 2016 Jun 14;37(23):1826-34. doi: 10.1093/eurheartj/ehv583. Epub 2015 Nov 3.
Grogan M, Scott CG, Kyle RA, Zeldenrust SR, Gertz MA, Lin G, Klarich KW, Miller WL, Maleszewski JJ, Dispenzieri A. Natural History of Wild-Type Transthyretin Cardiac Amyloidosis and Risk Stratification Using a Novel Staging System. J Am Coll Cardiol. 2016 Sep 6;68(10):1014-20. doi: 10.1016/j.jacc.2016.06.033.
Rapezzi C, Quarta CC, Guidalotti PL, Longhi S, Pettinato C, Leone O, Ferlini A, Salvi F, Gallo P, Gagliardi C, Branzi A. Usefulness and limitations of 99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid scintigraphy in the aetiological diagnosis of amyloidotic cardiomyopathy. Eur J Nucl Med Mol Imaging. 2011 Mar;38(3):470-8. doi: 10.1007/s00259-010-1642-7. Epub 2010 Nov 11.
Gillmore JD, Maurer MS, Falk RH, Merlini G, Damy T, Dispenzieri A, Wechalekar AD, Berk JL, Quarta CC, Grogan M, Lachmann HJ, Bokhari S, Castano A, Dorbala S, Johnson GB, Glaudemans AW, Rezk T, Fontana M, Palladini G, Milani P, Guidalotti PL, Flatman K, Lane T, Vonberg FW, Whelan CJ, Moon JC, Ruberg FL, Miller EJ, Hutt DF, Hazenberg BP, Rapezzi C, Hawkins PN. Nonbiopsy Diagnosis of Cardiac Transthyretin Amyloidosis. Circulation. 2016 Jun 14;133(24):2404-12. doi: 10.1161/CIRCULATIONAHA.116.021612. Epub 2016 Apr 22.
Other Identifiers
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209268
Identifier Type: -
Identifier Source: org_study_id
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