Registry of Patients With Suspected Amyloidosis in Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Registry of Patients With Suspected Amyloidosis in Heart Failure: Regamic

Conditions
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Heart Failure

Intervention / Treatment
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* Diagnostic Test: Bone-cardiac scintigraphy


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Age ≥ 18 years. Both genders. Heart Failure (2021 European Society of Cardiology criteria) Any LVEF value. Outpatients or hospitalized patients in Internal Medicine Units Patients with suspicion criteria proposed by the European Society of Cardiology: Ventricular hypertrophy ≥ 12 mm And one or more of the following criteria: Heart failure in ≥ 65 years Aortic stenosis in ≥ 65 years Hypotension or Normotensive if previously hypertensive Sensory involvement, autonomic dysfunction Peripheral polyneuropathy Proteinuria Skin bruising (eg, periorbital purpura) Bilateral carpal tunnel syndrome Ruptured biceps tendon In CMR: Subendocardial / transmural late gadolinium enhancement (LGE), or increased extracellular volume (ECV) In ECO: Reduced longitudinal strain with apical sparing Reduced QRS voltage to mass ratio Pseudo Q waves on ECG Atrioventricular conduction disease Possible family history of ATTRv EXCLUSION CRITERIA: Refusal to participate in the registry

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients in whom Cardiac Amyloidosis is confirmed | Diagnostic Test: Bone-cardiac scintigraphy<br>* Patients with confirmed ATTR type CA will undergo a study of mutations in the TTR gene<br>* Other names: Laboratory test to rule out monoclonal protein;|
| Group 2<br>Patients in whom Cardiac Amyloidosis is ruled out | Diagnostic Test: Bone-cardiac scintigraphy<br>* Patients with confirmed ATTR type CA will undergo a study of mutations in the TTR gene<br>* Other names: Laboratory test to rule out monoclonal protein;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differential characteristics between two groups | Number of biopsies performed between both groups. | Up to two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic differences between both groups | Readmission rate of patients with AC and without AC in a period of two years. | Up to two years | 
| Prognostic differences between two groups | Mortality rate of patients with AC and without AC in a period of two years. | Up to Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyloidosis