Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427304
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-04-24
Brief Title:
Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure
Sponsor:
Gérondif
Organization:
Gérondif
Study Overview
Official Title:
Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARNOLD
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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None