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

G

Gérond'if

Status

Enrolling

Conditions

Cardiac Amyloidosis

Study type

Observational

Funder types

Other

Identifiers

NCT06427304
2023-A01313-42

Details and patient eligibility

About

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

Full 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

Enrollment

637 estimated patients

Sex

All

Ages

80+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Isabelle Dufour; Prisca Lucas, MPH PhD

Data sourced from clinicaltrials.gov

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