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Amyloid CardiomyopathyAC-TIVENCT04738266

Unmasking the Prevalence of AC in an Unselected Echocardiographic Population

An observational study of Amyloid Cardiomyopathy, run by University of Trieste at 16 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will investigate the prevalence of echocardiographic red-flags of amyloid cardiomyopathy (AC) in patients undergoing clinically-indicated echocardiography (observational phase) and the prevalence of AC among AC-suggestive echocardiograms (interventional phase). Read more about this study

Who is it for?
Ages 55 to 100 years
Conditions the study is for
Amyloid Cardiomyopathy
What is being tested?
Amyloid Cardiomyopathy
How many people
381 participants
Where
16 sitesItaly
Study dates
20 Nov 2020to 25 Jul 2021
How long will I take part?
4 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive inpatients and outpatients subjects aged ≥55 years undergoing routine, clinically-indicated echocardiography at the laboratories of participating centers.

Who may be able to join

  • All the following:
  • Interventricular septum thickness ≥ 13 mm in men and ≥ 12 mm in women;
  • Left ventricular ejection fraction ≥ 50%;
  • Indexed end-diastolic left ventricular volume ≤ 85 mL/m2.
  • AND
  • At least one of the following criteria:
Show all 12Show fewer
  • "Granular sparkling" appearance of the myocardium defined granular texture with uniform increased brightness of echo-reflections;
  • Pericardial effusion regardless of severity;
  • Increased interatrial septum thickness (> 5 mm);
  • Restrictive filling pattern (Dec. Time E wave <120 ms or Dec. Time E wave ≤150 ms e E/A ratio ≥2) or increased ventricular filling pressures (E/E'15);
  • Speckle tracking derived global longitudinal strain with apical sparing pattern;
  • Increased thickness (> 5 mm) of mitral and tricuspid valve leaflets.

Who cannot join

  • Patients aged < 55 years or > 100 years
  • Echocardiography performed due to known or suspected amyloid cardiomyopathy;
  • Echocardiography performed due to known hypertrophic cardiomyopathy or phenocopies;
  • Refuse to sign the informed consent to the study

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Italy16 sites

  • Cardiology Unit, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro

    Bari, 70121

  • Cardiovascular Department, Policlinico Sant'Orsola

    Bologna, 40138

  • Cardiology, Department of Medical and Surgical Specialities, Radiological Sciences and Public Health - University of Brescia

    Brescia, 25100

  • Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara

    Ferrara, 44121

  • Cardiomyopathy Unit, Careggi University Hospital

    Florence, 50134

  • Cardiovascular Unit, Department of Internal Medicine, University of Genova

    Genova, 16126

  • Department of Cardiology, University of Messina

    Messina, 98122

  • Department of medicine and surgery, University Milano-Bicocca

    Milan, 20126

  • Department of Cardiovascular, Neural and Metabolic Sciences - Istituto Auxologico Italiano

    Milan, 20149

  • Department of Translational Medical Sciences, Inherited and Rare Heart Disease, Vanvitelli Cardiology, University of Campania Luigi Vanvitelli

    Naples, 80131

  • Emergency Department and Amyloid Research and Treatment Center, IRCCS Policlinico San Matteo Foundation, Department of Internal Medicine, University of Pavia

    Pavia, Milano, 27100

  • Istituto di Scienze della Vita, Scuola Superiore Sant'Anna

    Pisa, 56127

  • Department of Clinical and Molecular Medicine, Faculty of Medicine and Psychology, Sapienza University

    Roma, 00155

  • Division of Cardiology, University of Siena

    Siena, 53100

  • University Cardiology A.O.U., Città della Salute e della Scienza di Torino

    Torino, 10126

  • Centre for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI)

    Trieste, 34149

Other trials in Italy

About this study

Official title: A National Survey of Prevalence and Accuracy of Echocardiographic Red Flags of Amyloid Cardiomyopathy in Consecutive Patients Undergoing Routine Echocardiography.

This study will investigate the prevalence of echocardiographic red-flags of amyloid cardiomyopathy (AC) in patients undergoing clinically-indicated echocardiography (observational phase) and the prevalence of AC among AC-suggestive echocardiograms (interventional phase).

Read the detailed description

Prospective multicenter Italian survey consisting of two phases: observational (echocardiographic screening for amyloid cardiomyopathy among patients ≥ 55 years undergoing clinically-indicated echocardiography) and interventional (specific clinical and instrumental work-up to detect the prevalence of amyloid cardiomyopathy among amyloid cardiomyopathy-suggestive echocardiograms).

Being tested
Amyloid Cardiomyopathy
Keywords
Amyloid Cardiomyopathy, Echocardiography, Red flags, Epidemiology, Bone tracer cardiac scintigraphy
Medical subject headings
Amyloid Neuropathies, Familial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amyloid CardiomyopathyDiagnostic test

    Echocardiographic red flags of Amyloid Cardiomyopathy to guide the suspicion of disease and to proceed with second level diagnostic work up including cardiac scintigraphy with bone tracers and search of monoclonal component in serum and urine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The prevalence of Amyloid Cardiomyopathy

    The prevalence of Amyloid Cardiomyopathy in unselected echocardiographic population of patients aged > 55 years

    Measured: 3 months

  2. The prevalence of echocardiographic red flags of Amyloid Cardiomyopathy

    The prevalence of echocardiographic red flags of Amyloid Cardiomyopathy in unselected echocardiographic population of patients aged > 55 years

    Measured: 6 months

  3. The diagnostic accuracy of echocardiographic red flags of Amyloid Cardiomyopathy

    At the end of phase 2 of this study, patients with Amyloid Cardiomyopathy will be diagnosed, thus allowing to measure the diagnostic accuracy of the following echocardiographic red flags of Amyloid Cardiomyopathy:

    • Restrictive filling pattern (E wave deceleration time <120 ms or ≤150 ms in presence of E/A ≥2) and/or E/E'≥15;
    • "Granular sparkling" appearance of the myocardium;
    • Pericardial effusion of any entity;
    • Interatrial septum thickness >0.5 cm measured in subcostal or four-chamber view;
    • Thickening of the atrio-ventricular (AV) valves (leaflets thickness >0.5 cm);
    • Left ventricular "apical sparing" pattern at speckle-tracking echocardiography.

    Measured: 6 months

Secondary outcomes (1)

  1. Multiparametric echocardiographic score

    Multiparametric echocardiographic score to predict the presence of Amyloid Cardiomyopathy

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start20 Nov 2020
  3. Primary completion20 Jan 2021
  4. Study completion25 Jul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
381 participants (actual)
Target duration
4 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04738266
Sponsor's protocol ID
199_2019
Acronym
AC-TIVE
Status last verified
Feb 2021
First submitted
28 Jan 2021
Last updated
4 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Maurer MS, Bokhari S, Damy T, Dorbala S, Drachman BM, Fontana M, Grogan M, Kristen AV, Lousada I, Nativi-Nicolau J, Cristina Quarta C, Rapezzi C, Ruberg FL, Witteles R, Merlini G. Expert Consensus Recommendations for the Suspicion and Diagnosis of Transthyretin Cardiac Amyloidosis. Circ Heart Fail. 2019 Sep;12(9):e006075. doi: 10.1161/CIRCHEARTFAILURE.119.006075. Epub 2019 Sep 4.

    PubMed 31480867

  • Boldrini M, Cappelli F, Chacko L, Restrepo-Cordoba MA, Lopez-Sainz A, Giannoni A, Aimo A, Baggiano A, Martinez-Naharro A, Whelan C, Quarta C, Passino C, Castiglione V, Chubuchnyi V, Spini V, Taddei C, Vergaro G, Petrie A, Ruiz-Guerrero L, Monivas V, Mingo-Santos S, Mirelis JG, Dominguez F, Gonzalez-Lopez E, Perlini S, Pontone G, Gillmore J, Hawkins PN, Garcia-Pavia P, Emdin M, Fontana M. Multiparametric Echocardiography Scores for the Diagnosis of Cardiac Amyloidosis. JACC Cardiovasc Imaging. 2020 Apr;13(4):909-920. doi: 10.1016/j.jcmg.2019.10.011. Epub 2019 Dec 18.

    PubMed 31864973

  • 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.

    PubMed 27143678

  • 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.

    PubMed 28373528

  • Porcari A, Merlo M, Rapezzi C, Sinagra G. Transthyretin amyloid cardiomyopathy: An uncharted territory awaiting discovery. Eur J Intern Med. 2020 Dec;82:7-15. doi: 10.1016/j.ejim.2020.09.025. Epub 2020 Oct 5.

    PubMed 33032855

  • Maurer MS, Hanna M, Grogan M, Dispenzieri A, Witteles R, Drachman B, Judge DP, Lenihan DJ, Gottlieb SS, Shah SJ, Steidley DE, Ventura H, Murali S, Silver MA, Jacoby D, Fedson S, Hummel SL, Kristen AV, Damy T, Plante-Bordeneuve V, Coelho T, Mundayat R, Suhr OB, Waddington Cruz M, Rapezzi C; THAOS Investigators. Genotype and Phenotype of Transthyretin Cardiac Amyloidosis: THAOS (Transthyretin Amyloid Outcome Survey). J Am Coll Cardiol. 2016 Jul 12;68(2):161-72. doi: 10.1016/j.jacc.2016.03.596.

    PubMed 27386769

  • Merlo M, Pagura L, Porcari A, Cameli M, Vergaro G, Musumeci B, Biagini E, Canepa M, Crotti L, Imazio M, Forleo C, Cappelli F, Perfetto F, Favale S, Di Bella G, Dore F, Girardi F, Tomasoni D, Pavasini R, Rella V, Palmiero G, Caiazza M, Carella MC, Igoren Guaricci A, Branzi G, Caponetti AG, Saturi G, La Malfa G, Merlo AC, Andreis A, Bruno F, Longo F, Rossi M, Varra GG, Saro R, Di Ienno L, De Carli G, Giacomin E, Arzilli C, Limongelli G, Autore C, Olivotto I, Badano L, Parati G, Perlini S, Metra M, Emdin M, Rapezzi C, Sinagra G. Unmasking the prevalence of amyloid cardiomyopathy in the real world: results from Phase 2 of the AC-TIVE study, an Italian nationwide survey. Eur J Heart Fail. 2022 Aug;24(8):1377-1386. doi: 10.1002/ejhf.2504. Epub 2022 May 10.

    PubMed 35417089

Questions about this trial

What is this clinical trial studying?

An observational study of Amyloid Cardiomyopathy, run by University of Trieste at 16 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The prevalence of Amyloid Cardiomyopathy (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04738266, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.

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