Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure

Cardiac Amyloidosis Clinical Trial

— ARNOLD  

Official title:

Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427304
• Other study ID #: 2023-A01313-42
• Status: Not yet recruiting
• Start date: May 30, 2024
• Est. completion date: December 2, 2027

Study information

• Verified date: May 2024
• Source: Gérond'if
• Contact: Isabelle Dufour
• Phone: +33 (0) 185781011
• Email: isabelle.dufour[@]gerondif.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 637
• Est. completion date: December 2, 2027
• Est. primary completion date: May 2, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis
• Heart Failure

Locations

Country	Name	City	State
France	Geriatric Department, Broca Hospital	Paris	IIe-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Gérond'if

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the number of patients with cardiac amyloidosis according bon scintigraphy		At inclusion
Secondary	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.	At inclusion
Secondary	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.	At inclusion
Secondary	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)	At inclusion
Secondary	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%.	At inclusion
Secondary	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	At inclusion
Secondary	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	At inclusion