Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure

NCT06427304 | Recruiting DMC

• 1 other identifier: 2023-A01313-42
• Study Type: observational
• Target: 637
• Locations: 1 country
• Sites: 36

Brief Summary

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

Conditions

Cardiac Amyloidosis

Keywords

Cardiac amyloidosis; Heart failure with left ventricular hypertrophy; Positive bone scintigraphy

Outcome Measures

Primary Outcomes (1)

• Assessment of the number of patients with cardiac amyloidosis according bon scintigraphy

  At inclusion

Secondary Outcomes (6)

• Assessment of commorbidity risk according Charlson Comorbidity Index (CCI)

  At inclusion

• Assessment of the degree of patient dependence according Katz Index of Independence in Activities of Daily Living (ADL)

  At inclusion

• Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score

  At inclusion

• Estimating the probability of neuropathic pain according "DN4 Questionnaire"

  At inclusion

• Assessment of physical frailty according Fried scale

  At inclusion

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cardiac amyloidosis expressed by a positive bone scintigraphy.

You may qualify if:

• 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

You may not qualify if:

• Subjects refusing to participate
• Subjects admitted to palliative care unit.
• Subjects under guardianship
• Subjects with a definite diagnosis of cardiac amyloidosis

Sponsors & Collaborators

• Gérond'if: lead

Study Sites (36)

Geriatric Department, Broca Hospital

Paris, IIe-de-France, 75013, France

RECRUITING

CHU Nantes

Nantes, Loire-Atlantique, 44000, France

RECRUITING

CHU Poitiers

Poitiers, New Aquitaine, 86000, France

RECRUITING

CHU Rouen, Charles Nicole hospital

Rouen, Normandy, 76000, France

RECRUITING

CHU Montpellier

Montpellier, Occitanie, 34090, France

RECRUITING

CHU Toulouse

Toulouse, Occitanie, 31300, France

RECRUITING

CHU Amiens Picardie

Amiens, 80000, France

RECRUITING

CHU Angers

Angers, 49100, France

RECRUITING

CHU Bordeaux

Bordeaux, 33000, France

RECRUITING

Centre Hospitalier de Carcassonne

Carcassonne, 11100, France

RECRUITING

Centre Hospitalier Intercommunal de Castres-Mazamet

Castres, 81100, France

RECRUITING

CHU Trousseau-Tours

Chambray-lès-Tours, 37170, France

RECRUITING

CHU Dijon

Dijon, 21000, France

RECRUITING

CHU Grenoble Alpes

Grenoble, 38700, France

RECRUITING

CHU Lille

Lille, 59000, France

RECRUITING

CHU Limoges

Limoges, 87000, France

RECRUITING

CHU Lyon

Lyon, 69002, France

RECRUITING

CHU Marseille

Marseille, 13005, France

RECRUITING

Clinique du Millénaire-Montpellier

Montpellier, 34000, France

RECRUITING

CHRU Nancy

Nancy, 54000, France

RECRUITING

CHU Nice

Nice, 06000, France

RECRUITING

Hôpital Privé Gériatrique LES SOURCES-Nice

Nice, 06100, France

RECRUITING

CHU Orléans

Orléans, 45100, France

RECRUITING

CHU Rennes

Rennes, 35000, France

RECRUITING

CHRU Tours-Bretonneau Hospital

Tours, 37000, France

RECRUITING

Clinique Saint Joseph Trelaze

Trélazé, 49800, France

RECRUITING

Médipôle Hôpital Mutualiste Villeurbanne

Villeurbanne, 69100, France

RECRUITING

Ambroise Paré Hospital

Boulogne-Billancourt, Île-de-France Region, 92100, France

RECRUITING

Corentin Celton Hospital

Issy-les-Moulineaux, Île-de-France Region, 92130, France

NOT YET RECRUITING

Charles Foix Hospital

Ivry-sur-Seine, Île-de-France Region, 94200, France

RECRUITING

Emile Roux Hospital

Limeil-Brévannes, Île-de-France Region, 94450, France

RECRUITING

GH Sud Ile-de-France

Melun, Île-de-France Region, 77000, France

RECRUITING

Lariboisière Hospital

Paris, Île-de-France Region, 75010, France

RECRUITING

Saint Joseph Hospital

Paris, Île-de-France Region, 75014, France

RECRUITING

Europeen Georges Pompidou Hospital

Paris, Île-de-France Region, 75015, France

RECRUITING

Bretonneau Hospital

Paris, Île-de-France Region, 75018, France

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

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

Study Officials

• Olivier Hanon, MD PhD

  Geriatric Department, Broca hospital

  STUDY CHAIR

Central Study Contacts

Isabelle Dufour

CONTACT

+33 (0) 185781011; isabelle.dufour@gerondif.org

Prisca Lucas, MPH PhD

CONTACT

+33 (0)185737323; prisca.lucas@gerondif.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 23, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 2, 2027
• Study Completion (Estimated): February 2, 2028
• Last Updated: April 20, 2026

Record last verified: 2025-12

Locations

FR (36)