Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure (ARNOLD)

April 15, 2026 updated by: Gérond'if
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

Study Overview

Status

Recruiting

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

637

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80000
        • Recruiting
        • CHU Amiens Picardie
        • Contact:
          • Nysrine BENNOUNA, MD
      • Angers, France, 49100
        • Recruiting
        • CHU Angers
        • Contact:
          • Cédric NNWEILER, MD, PHD
      • Bordeaux, France, 33000
        • Recruiting
        • CHU Bordeaux
        • Contact:
          • Isabelle BOURDEL-MARCHASSON, MD, PHD
      • Carcassonne, France, 11100
        • Recruiting
        • Centre Hospitalier de Carcassonne
        • Contact:
          • Hanna BAKANOVA, Dr
      • Castres, France, 81100
        • Recruiting
        • Centre Hospitalier Intercommunal de Castres-Mazamet
        • Contact:
          • Soumiya MENHOUR, MD
      • Chambray-lès-Tours, France, 37170
        • Recruiting
        • CHU Trousseau-Tours
        • Contact:
          • Laurent FAUCHIER, MD, PHD
      • Dijon, France, 21000
        • Recruiting
        • CHU Dijon
        • Contact:
          • Jérémie VOVELLE, MD
      • Grenoble, France, 38700
        • Recruiting
        • CHU Grenoble Alpes
        • Contact:
          • Laure ALLAN-PATTOGLIA, MD
      • Lille, France, 59000
        • Recruiting
        • CHU Lille
        • Contact:
          • François PUISIEUX, MD, PHD
      • Limoges, France, 87000
        • Recruiting
        • CHU Limoges
        • Contact:
          • Achille TCHALLA, MD
      • Lyon, France, 69002
        • Recruiting
        • CHU Lyon
        • Contact:
          • Michel CHUZEVILLE, MD
      • Marseille, France, 13005
        • Recruiting
        • CHU Marseille
        • Contact:
          • Anne-Laure COUDERC, MD, PHD
      • Montpellier, France, 34000
        • Recruiting
        • Clinique du Millénaire-Montpellier
        • Contact:
          • Philippe GALLET DE SANTERRE, Dr
      • Nancy, France, 54000
        • Recruiting
        • CHRU Nancy
        • Contact:
          • Laure JOLY, MD
      • Nice, France, 06000
        • Recruiting
        • CHU Nice
        • Contact:
          • Olivier GUERIN, MD, PHD
      • Nice, France, 06100
        • Recruiting
        • Hôpital Privé Gériatrique LES SOURCES-Nice
        • Contact:
          • Anne-Marie BARISIC, MD
      • Orléans, France, 45100
        • Recruiting
        • Chu Orleans
        • Contact:
          • Matthieu COULONGEAT, MD
      • Rennes, France, 35000
        • Recruiting
        • CHU Rennes
        • Contact:
          • Dominique SOMME, MD, PHD
        • Contact:
          • Erwan DONAL, MD, PhD
      • Tours, France, 37000
        • Recruiting
        • CHRU Tours-Bretonneau Hospital
        • Contact:
          • Bertrand FOUGERE, MD, PHD
      • Trélazé, France, 49800
        • Recruiting
        • Clinique Saint Joseph Trelaze
        • Contact:
          • Laureen LABORY, MD
      • Villeurbanne, France, 69100
        • Recruiting
        • Médipôle Hôpital Mutualiste Villeurbanne
        • Contact:
          • Antoine JOBBE-DUVAL, MD
    • IIe-de-France
      • Paris, IIe-de-France, France, 75013
        • Recruiting
        • Geriatric Department, Broca Hospital
        • Contact:
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44000
        • Recruiting
        • CHU Nantes
        • Contact:
          • Anne Sophie BOUREAU, MD
    • New Aquitaine
      • Poitiers, New Aquitaine, France, 86000
        • Recruiting
        • CHU Poitiers
        • Contact:
          • Marc PACCALIN, MD, PHD
    • Normandy
      • Rouen, Normandy, France, 76000
        • Recruiting
        • CHU Rouen, Charles Nicole hospital
        • Contact:
          • Frédéric ROCA, MD
    • Occitanie
      • Montpellier, Occitanie, France, 34090
        • Recruiting
        • CHU Montpellier
        • Contact:
          • Hubert BLAIN, MD, PHD
      • Toulouse, Occitanie, France, 31300
        • Recruiting
        • CHU Toulouse
        • Contact:
          • Olivier TOULZA, MD
    • Île-de-France Region
      • Boulogne-Billancourt, Île-de-France Region, France, 92100
        • Recruiting
        • Ambroise Paré Hospital
        • Contact:
          • Marion PEPIN, MD
      • Issy-les-Moulineaux, Île-de-France Region, France, 92130
        • Not yet recruiting
        • Corentin Celton Hospital
        • Contact:
          • Anthony MEZIERE, MD
      • Ivry-sur-Seine, Île-de-France Region, France, 94200
        • Recruiting
        • Charles Foix Hospital
        • Contact:
          • Joël BELMIN, MD, PHD
      • Limeil-Brévannes, Île-de-France Region, France, 94450
        • Recruiting
        • Emile Roux Hospital
        • Contact:
          • Amaury BROUSSIER, MD
      • Melun, Île-de-France Region, France, 77000
        • Recruiting
        • GH Sud Ile-de-france
        • Contact:
          • Cyrus MOÏNI, MD
      • Paris, Île-de-France Region, France, 75010
        • Recruiting
        • Lariboisiere Hospital
        • Contact:
          • Matthieu LILAMAND, MD
      • Paris, Île-de-France Region, France, 75014
        • Recruiting
        • Saint Joseph Hospital
        • Contact:
          • Yara ANTAKLY HANON, MD
      • Paris, Île-de-France Region, France, 75015
        • Recruiting
        • Europeen Georges Pompidou Hospital
        • Contact:
          • Elena PAILLAUD, MD, PHD
      • Paris, Île-de-France Region, France, 75018
        • Recruiting
        • Bretonneau Hospital
        • Contact:
          • Virginie FOSSEY-DIAZ, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with cardiac amyloidosis expressed by a positive bone scintigraphy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the number of patients with cardiac amyloidosis according bon scintigraphy
Time Frame: At inclusion
At inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of commorbidity risk according Charlson Comorbidity Index (CCI)
Time Frame: At inclusion
The Charlson Comorbidity Index (CCI) assesses the level of comorbidity by considering the level of severity of 19 predefined comorbid disorders and the number of disorders present among them.
At inclusion
Assessment of the degree of patient dependence according Katz Index of Independence in Activities of Daily Living (ADL)
Time Frame: At inclusion

Katz Index of Independence in Activities of Daily Living is an unabbreviated scale title.

This Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Patients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
At inclusion
Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score
Time Frame: At inclusion

The Mini-Mental State Examination is an unabbreviated scale title. This scale was developed as a brief screening tool to provide a quantitative evaluation of cognitive impairment and to record cognitive changes over time.

The measure yields a total score of 30. A score of 23 or less is the generally accepted cutoff point indicating the presence of cognitive impairment. Levels of impairment have also been classified as none (24-30); mild (18-23) and severe (0-17)
At inclusion
Estimating the probability of neuropathic pain according "DN4 Questionnaire"
Time Frame: At inclusion

This questionnaire is an unabbreviated score title, it was originally developed and validated in French (4 items of neuropathic pain). It was identified as one of the most suitable neuropathic pain screening tools for clinical use:

  • Sensitivity: Ranges from 75-98%. Proven high sensitivity for central neuropathic pain and polyneuropathies. Sensitivity is low for tigeminal neuralgia. Moderate sensitivity for detecting a neuropathic component of pain in people with chronic pain.
  • Specificity: Ranges from 37-96%.
At inclusion
Assessment of physical frailty according Fried scale
Time Frame: At inclusion

This is an unabbreviated scale title.

Assessment of 5 dimensions:

  • 0, 1 or 2 pathological dimensions = lack of frailty
  • 3, 4 or 5 pathological dimensions = presence of frailty
At inclusion
Assessment of Failty status using the Short Emergency Geriatric Assessment (SEGA)
Time Frame: At inclusion

This is an unabbreviated scale title.

  • if SEGA score < ou = 8 : Not very frail
  • if it contained in the interval [9;11] : Rather frail
  • if it > ou = 12 : Very frail
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gérond'if

Investigators

  • Study Chair: Olivier Hanon, MD PhD, Geriatric Department, Broca Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

July 2, 2027

Study Completion (Estimated)

February 2, 2028

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

May 21, 2024

First Posted (Actual)

May 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A01313-42

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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