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Cardiac AmyloidosisARNOLDNCT06427304

Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure

An observational study of Cardiac Amyloidosis, run by Gérond'if at 36 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 80 years and older
Conditions the study is for
Cardiac Amyloidosis
How many people
637 participants
Where
36 sitesFrance
Study dates
1 Jul 2024to 2 Feb 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Patients with cardiac amyloidosis expressed by a positive bone scintigraphy.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

36 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Isabelle Dufour contact

+33 (0) 185781011

isabelle.dufour@gerondif.org

Prisca Lucas, MPH PhD contact

+33 (0)185737323

prisca.lucas@gerondif.org

36 sites in 1 country

France36 sites, 36 recruiting

  • CHU Amiens Picardie

    Amiens, 80000

    Nysrine BENNOUNA, MD

    Recruiting

  • CHU Angers

    Angers, 49100

    Cédric NNWEILER, MD, PHD

    Recruiting

  • CHU Bordeaux

    Bordeaux, 33000

    Isabelle BOURDEL-MARCHASSON, MD, PHD

    Recruiting

  • Ambroise Paré Hospital

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

    Marion PEPIN, MD

    Recruiting

  • Centre Hospitalier de Carcassonne

    Carcassonne, 11100

    Hanna BAKANOVA, Dr

    Recruiting

  • Centre Hospitalier Intercommunal de Castres-Mazamet

    Castres, 81100

    Soumiya MENHOUR, MD

    Recruiting

  • CHU Trousseau-Tours

    Chambray-lès-Tours, 37170

    Laurent FAUCHIER, MD, PHD

    Recruiting

  • CHU Dijon

    Dijon, 21000

    Jérémie VOVELLE, MD

    Recruiting

  • CHU Grenoble Alpes

    Grenoble, 38700

    Laure ALLAN-PATTOGLIA, MD

    Recruiting

  • Corentin Celton Hospital

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

    Anthony MEZIERE, MD

    Not yet recruiting

  • Charles Foix Hospital

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

    Joël BELMIN, MD, PHD

    Recruiting

  • CHU Lille

    Lille, 59000

    François PUISIEUX, MD, PHD

    Recruiting

  • Emile Roux Hospital

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

    Amaury BROUSSIER, MD

    Recruiting

  • CHU Limoges

    Limoges, 87000

    Achille TCHALLA, MD

    Recruiting

  • CHU Lyon

    Lyon, 69002

    Michel CHUZEVILLE, MD

    Recruiting

  • CHU Marseille

    Marseille, 13005

    Anne-Laure COUDERC, MD, PHD

    Recruiting

  • GH Sud Ile-de-France

    Melun, Île-de-France Region, 77000

    Cyrus MOÏNI, MD

    Recruiting

  • CHU Montpellier

    Montpellier, Occitanie, 34090

    Hubert BLAIN, MD, PHD

    Recruiting

  • Clinique du Millénaire-Montpellier

    Montpellier, 34000

    Philippe GALLET DE SANTERRE, Dr

    Recruiting

  • CHRU Nancy

    Nancy, 54000

    Laure JOLY, MD

    Recruiting

  • CHU Nantes

    Nantes, Loire-Atlantique, 44000

    Anne Sophie BOUREAU, MD

    Recruiting

  • CHU Nice

    Nice, 06000

    Olivier GUERIN, MD, PHD

    Recruiting

  • Hôpital Privé Gériatrique LES SOURCES-Nice

    Nice, 06100

    Anne-Marie BARISIC, MD

    Recruiting

  • CHU Orléans

    Orléans, 45100

    Matthieu COULONGEAT, MD

    Recruiting

  • Geriatric Department, Broca Hospital

    Paris, IIe-de-France, 75013

    Olivier Hanon, MD PhD, +33 (0)144083503, olivier.hanon@aphp.fr

    Recruiting

  • Lariboisière Hospital

    Paris, Île-de-France Region, 75010

    Matthieu LILAMAND, MD

    Recruiting

  • Saint Joseph Hospital

    Paris, Île-de-France Region, 75014

    Yara ANTAKLY HANON, MD

    Recruiting

  • Europeen Georges Pompidou Hospital

    Paris, Île-de-France Region, 75015

    Elena PAILLAUD, MD, PHD

    Recruiting

  • Bretonneau Hospital

    Paris, Île-de-France Region, 75018

    Virginie FOSSEY-DIAZ, MD

    Recruiting

  • CHU Poitiers

    Poitiers, New Aquitaine, 86000

    Marc PACCALIN, MD, PHD

    Recruiting

  • CHU Rennes

    Rennes, 35000

    Dominique SOMME, MD, PHD

    Erwan DONAL, MD, PhD

    Recruiting

  • CHU Rouen, Charles Nicole hospital

    Rouen, Normandy, 76000

    Frédéric ROCA, MD

    Recruiting

  • CHU Toulouse

    Toulouse, Occitanie, 31300

    Olivier TOULZA, MD

    Recruiting

  • CHRU Tours-Bretonneau Hospital

    Tours, 37000

    Bertrand FOUGERE, MD, PHD

    Recruiting

  • Clinique Saint Joseph Trelaze

    Trélazé, 49800

    Laureen LABORY, MD

    Recruiting

  • Médipôle Hôpital Mutualiste Villeurbanne

    Villeurbanne, 69100

    Antoine JOBBE-DUVAL, MD

    Recruiting

Other trials in France

About this study

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

Read the 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

Keywords
Cardiac amyloidosis, Heart failure with left ventricular hypertrophy, Positive bone scintigraphy
Medical subject headings
Amyloid Neuropathies, Familial

What is being measured

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

  1. Assessment of the number of patients with cardiac amyloidosis according bon scintigraphy

    Measured: At inclusion

Secondary outcomes (6)

  1. Assessment of commorbidity risk according Charlson Comorbidity Index (CCI)

    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.

    Measured: At inclusion

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

    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.

    Measured: At inclusion

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

    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)

    Measured: At inclusion

  4. Estimating the probability of neuropathic pain according "DN4 Questionnaire"

    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%.

    Measured: At inclusion

  5. Assessment of physical frailty according Fried scale

    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

    Measured: At inclusion

  6. Assessment of Failty status using the Short Emergency Geriatric Assessment (SEGA)

    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

    Measured: At inclusion

Timeline

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

  1. First posted23 May 2024
  2. Study start1 Jul 2024
  3. Primary completion2 Jul 2027 (estimated)
  4. Study completion2 Feb 2028 (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
Case only
Time perspective
Prospective
Enrolment
637 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06427304
Sponsor's protocol ID
2023-A01313-42
Acronym
ARNOLD
Status last verified
Dec 2025
First submitted
24 Apr 2024
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Amyloidosis, run by Gérond'if at 36 sites in France.

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 5 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in France. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Isabelle Dufour (+33 (0) 185781011, isabelle.dufour@gerondif.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the number of patients with cardiac amyloidosis according bon scintigraphy (time frame: At inclusion). 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 NCT06427304.

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 20 Apr 2026.

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