Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure

NCT ID: NCT06427304

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

637 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2028-02-02

Brief Summary

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Tne aim purpose of this observational, multicentre and propective study is to determine the prevalence of cardiac amyloidosis in geriatric patients aged 80 years and older hospitalized within the last 12 months for heart failure with left ventricular hypertrophy (septum ≥ 12 mm) on echocardiography

Detailed Description

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Patients recruitment will be curry out in 31 geriatric or cardiologic centres.

Patients will be recruited for 24 months. Each patient will participate in the study for 12 months (baseline visit, follow-up phone calls every 3 months up to 12 months i.e., at 3, 6, 9 and 12 months).

The following data will be collected at teh baseline visit: Medical history, demography, clinical data, frailty status assessed by Fried, Triage Risk Screening Tool (TRST), triggers for cardiac decompensation, biological examination, genetic testing, echocardiographic data and other data.

Bone scanning with 99mTc-DPD or 99mTc-HMDP (early or late time with SPECT will be done during hospitalization or after discharge depending on availability at the imaging centre.

The results of each examination will be evaluated to establish the existence and degree of fixation in the myocardium and to determine its distribution.

Follow-up phone s will be conducted every 3 months up to 12 months to collect hospitalizations for heart failure, hospitalizations for other cardio-vascular events, hospitalizations for non-cardiac events, admission to nursing homes or long-term care (LTC) facilities and death

Conditions

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Cardiac Amyloidosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Aged ≥ 80 years
* Hospitalised for decompensation of heart failure in the last 12 months
* Subjects with hypertrophy of the septum or left ventricle at cardiac echography (defined as ≥ 12 mm)
* Subjects able to undergo a bone scintigraphy scan
* Subjects willing to participate

Exclusion Criteria

* Subjects refusing to participate
* Subjects admitted to palliative care unit.
* Subjects under guardianship
* Subjects with a definite diagnosis of cardiac amyloidosis
Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gérond'if

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Hanon, MD PhD

Role: STUDY_CHAIR

Geriatric Department, Broca hospital

Locations

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Geriatric Department, Broca Hospital

Paris, IIe-de-France, France

Site Status RECRUITING

CHU Nantes

Nantes, Loire-Atlantique, France

Site Status RECRUITING

CHU Rouen, Charles Nicole hospital

Rouen, Normandy, France

Site Status RECRUITING

CHU Poitiers

Poitiers, Nouvelle-Aquitaine, France

Site Status RECRUITING

CHU Montpellier

Montpellier, Occitanie, France

Site Status RECRUITING

CHU Toulouse

Toulouse, Occitanie, France

Site Status RECRUITING

CHU Amiens Picardie

Amiens, , France

Site Status RECRUITING

CHU Angers

Angers, , France

Site Status RECRUITING

CHU Bordeaux

Bordeaux, , France

Site Status RECRUITING

Centre Hospitalier de Carcassonne

Carcassonne, , France

Site Status RECRUITING

Centre Hospitalier Intercommunal de Castres-Mazamet

Castres, , France

Site Status RECRUITING

CHU Trousseau-Tours

Chambray-lès-Tours, , France

Site Status RECRUITING

CHU Dijon

Dijon, , France

Site Status RECRUITING

CHU Grenoble Alpes

Grenoble, , France

Site Status RECRUITING

CHU Lille

Lille, , France

Site Status RECRUITING

CHU Limoges

Limoges, , France

Site Status RECRUITING

CHU Lyon

Lyon, , France

Site Status RECRUITING

CHU Marseille

Marseille, , France

Site Status RECRUITING

Clinique du Millénaire-Montpellier

Montpellier, , France

Site Status RECRUITING

CHRU Nancy

Nancy, , France

Site Status RECRUITING

CHU Nice

Nice, , France

Site Status RECRUITING

Hôpital Privé Gériatrique LES SOURCES-Nice

Nice, , France

Site Status NOT_YET_RECRUITING

CHU Orléans

Orléans, , France

Site Status RECRUITING

CHU Rennes

Rennes, , France

Site Status RECRUITING

CHRU Tours-Bretonneau Hospital

Tours, , France

Site Status RECRUITING

Clinique Saint Joseph Trelaze

Trélazé, , France

Site Status RECRUITING

Médipôle Hôpital Mutualiste Villeurbanne

Villeurbanne, , France

Site Status RECRUITING

Ambroise Paré Hospital

Boulogne-Billancourt, Île-de-France Region, France

Site Status RECRUITING

Corentin Celton Hospital

Issy-les-Moulineaux, Île-de-France Region, France

Site Status NOT_YET_RECRUITING

Charles Foix Hospital

Ivry-sur-Seine, Île-de-France Region, France

Site Status RECRUITING

Emile Roux Hospital

Limeil-Brévannes, Île-de-France Region, France

Site Status RECRUITING

GH Sud Ile-de-France

Melun, Île-de-France Region, France

Site Status RECRUITING

Lariboisière Hospital

Paris, Île-de-France Region, France

Site Status RECRUITING

Saint Joseph Hospital

Paris, Île-de-France Region, France

Site Status RECRUITING

Europeen Georges Pompidou Hospital

Paris, Île-de-France Region, France

Site Status RECRUITING

Bretonneau Hospital

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Isabelle Dufour

Role: CONTACT

+33 (0) 185781011

Prisca Lucas, MPH PhD

Role: CONTACT

+33 (0)185737323

Facility Contacts

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Olivier Hanon, MD PhD

Role: primary

+33 (0)144083503

Anne Sophie BOUREAU, MD

Role: primary

Frédéric ROCA, MD

Role: primary

Marc PACCALIN, MD, PHD

Role: primary

Hubert BLAIN, MD, PHD

Role: primary

Olivier TOULZA, MD

Role: primary

Nysrine BENNOUNA, MD

Role: primary

Cédric NNWEILER, MD, PHD

Role: primary

Isabelle BOURDEL-MARCHASSON, MD, PHD

Role: primary

Hanna BAKANOVA, Dr

Role: primary

Soumiya MENHOUR, MD

Role: primary

Laurent FAUCHIER, MD, PHD

Role: primary

Jérémie VOVELLE, MD

Role: primary

Laure ALLAN-PATTOGLIA, MD

Role: primary

François PUISIEUX, MD, PHD

Role: primary

Achille TCHALLA, MD

Role: primary

Michel CHUZEVILLE, MD

Role: primary

Anne-Laure COUDERC, MD, PHD

Role: primary

Philippe GALLET DE SANTERRE, Dr

Role: primary

Laure JOLY, MD

Role: primary

Olivier GUERIN, MD, PHD

Role: primary

Anne-Marie BARISIC, MD

Role: primary

Matthieu COULONGEAT, MD

Role: primary

Dominique SOMME, MD, PHD

Role: primary

Erwan DONAL, MD, PhD

Role: backup

Bertrand FOUGERE, MD, PHD

Role: primary

Laureen LABORY, MD

Role: primary

Antoine JOBBE-DUVAL, MD

Role: primary

Marion PEPIN, MD

Role: primary

Anthony MEZIERE, MD

Role: primary

Joël BELMIN, MD, PHD

Role: primary

Amaury BROUSSIER, MD

Role: primary

Cyrus MOÏNI, MD

Role: primary

Matthieu LILAMAND, MD

Role: primary

Yara ANTAKLY HANON, MD

Role: primary

Elena PAILLAUD, MD, PHD

Role: primary

Virginie FOSSEY-DIAZ, MD

Role: primary

Other Identifiers

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2023-A01313-42

Identifier Type: -

Identifier Source: org_study_id

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