Clinical trial NCT06427304: Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure
Official title: Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Amyloidosis
Keywords: Cardiac amyloidosis
Heart failure with left ventricular hypertrophy
Positive bone scintigraphy
Lead sponsor: Gérond'if
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 637
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cardiac amyloidosis expressed by a positive bone scintigraphy.

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the number of patients with cardiac amyloidosis according bon scintigraphy
timeFrame: At inclusion
Secondary outcomes:
measure: Assessment of commorbidity risk according Charlson Comorbidity Index (CCI)
timeFrame: At inclusion
measure: Assessment of the degree of patient dependence according Katz Index of Independence in Activities of Daily Living (ADL)
timeFrame: At inclusion
measure: Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score
timeFrame: At inclusion
measure: Estimating the probability of neuropathic pain according "DN4 Questionnaire"
timeFrame: At inclusion
measure: Assessment of physical frailty according Fried scale
timeFrame: At inclusion
measure: Assessment of Failty status using the Short Emergency Geriatric Assessment (SEGA)
timeFrame: At inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Geriatric Department, Broca Hospital
state: IIe-de-France
Study officials:
affiliation: Geriatric Department, Broca hospital
name: Olivier Hanon, MD PhD
role: STUDY_CHAIR
References: