Registry of Patients With Suspected Amyloidosis in Heart Failure — Regamic  

Heart Failure Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Amyloidosis
• Heart Failure

• NCT number: NCT05176548
• Study type: Observational [Patient Registry]
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Oscar Aramburu-Bodas, MD, PhD
• Phone: + 34 654038491
• Email: OSCARAB2000@GMAIL.COM
• Status: Recruiting
• Start date: January 15, 2022
• Completion date: December 31, 2025