Registry of Patients with Suspected Amyloidosis in Heart Failure (Regamic)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status

Active, not recruiting

Conditions

Heart Failure

Treatments

Diagnostic Test: Bone-cardiac scintigraphy

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05176548

REGAMIC-1450-N-21

Details and patient eligibility

About

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.

Full 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.

Enrollment

450 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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