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NCT Number: NCT06427304

Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure

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

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Key information

Conditions

Cardiac Amyloidosis Amyloid Neuropathies Amyloid Neuropathies, Familial Amyloidosis Amyloidosis, Familial Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Proteostasis Deficiencies

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geriatric Department, Broca Hospital, Paris, IIe-de-France, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: At inclusion

Secondary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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%.

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle Dufour

CONTACT

[email protected]

+33 (0) 185781011

Prisca Lucas, MPH PhD

CONTACT

[email protected]

+33 (0)185737323

Sponsors and collaborators

Lead sponsor

Gérond'if

Other

Registry information

Acronym: ARNOLD

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 23, 2024
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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