Ignite Creation Date:
2024-05-06 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05176548
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-15
First Post:
2021-11-08
Brief Title:
Registry of Patients with Suspected Amyloidosis in Heart Failure
Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Organization:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study Overview
Official Title:
Registry of Patients with Suspected Amyloidosis in Heart Failure Regamic
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
Regamic
Brief Summary:
Observational multicenter registry of cohorts with follow-up
Patients with heart failure age 18 years with clinical suspicion of cardiac amyloidosis and any LVEF value treated in the field of Internal Medicine
Initially a duration of two years was established to recruit at least 150 patients in the group with AC and a follow-up of two years
Upon completion of the two years of follow-up the continuity or completion of the registry will be assessed
Patients with heart failure age 18 years with clinical suspicion of cardiac amyloidosis and any LVEF value treated in the field of Internal Medicine
Initially a duration of two years was established to recruit at least 150 patients in the group with AC and a follow-up of two years
Upon completion of the two years of follow-up the continuity or completion of the registry will be assessed
Detailed Description:
Observational cohort study with a duration of two years to recruit at least 150 patients in the group with CA and a follow-up of two years The investigators estimate a sample size of at least 150 patients in the Group 1 CA confirmed and a total of 450 patients
The primary objectives of this study are
To evaluate differential characteristics between two groups of patients with Heart
Failure with clinical suspicion of Cardiac Amyloidosis CA
Group 1 Patients in whom CA is confirmed
Group 2 Patients in whom CA is ruled out
Clinical laboratory electrocardiographic echocardiographic characteristics and other studies MRI biopsies etc will be compared between both groups
The secondary objectives are
To evaluate the clinical and complementary test data on which the suspicion of the diagnosis of AC has been based
To identify prognostic differences between both groups by comparing readmission rates mortality and other events of patients with CA and without CA in a period of two years
The patients included in the study are elderly patients of both genders with heart failure who have undergone an echocardiogram in the last 24 months with a clinical suspicion of amyloidosis
All patients who meet inclusion criteria will be included from January 2022 to December 2023
The following studies are performed on each patient
Clinical laboratory electrocardiographic echocardiographic
Bone-cardiac scintigraphy
Laboratory test to rule out monoclonal protein
The number of readmissions emergency room visits and mortality in the 24 months following their inclusion will be recorded
A descriptive analysis of the data and a comparative analysis will be made in relation to different variables The association of different variables with readmission and mortality data will be assessed using univariate and multivariate analysis An analysis of survival curves will also be performed using the Kaplan-Meier method using the log-rank test
The primary objectives of this study are
To evaluate differential characteristics between two groups of patients with Heart
Failure with clinical suspicion of Cardiac Amyloidosis CA
Group 1 Patients in whom CA is confirmed
Group 2 Patients in whom CA is ruled out
Clinical laboratory electrocardiographic echocardiographic characteristics and other studies MRI biopsies etc will be compared between both groups
The secondary objectives are
To evaluate the clinical and complementary test data on which the suspicion of the diagnosis of AC has been based
To identify prognostic differences between both groups by comparing readmission rates mortality and other events of patients with CA and without CA in a period of two years
The patients included in the study are elderly patients of both genders with heart failure who have undergone an echocardiogram in the last 24 months with a clinical suspicion of amyloidosis
All patients who meet inclusion criteria will be included from January 2022 to December 2023
The following studies are performed on each patient
Clinical laboratory electrocardiographic echocardiographic
Bone-cardiac scintigraphy
Laboratory test to rule out monoclonal protein
The number of readmissions emergency room visits and mortality in the 24 months following their inclusion will be recorded
A descriptive analysis of the data and a comparative analysis will be made in relation to different variables The association of different variables with readmission and mortality data will be assessed using univariate and multivariate analysis An analysis of survival curves will also be performed using the Kaplan-Meier method using the log-rank test
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