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

Registry of Patients with Suspected Amyloidosis in Heart Failure: Regamic

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Diagnostic test: Bone-cardiac scintigraphy

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.

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41071
    • Hospital Universitario Virgen Macarena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Diagnostic Test: Bone-cardiac scintigraphy with Tc-DPD (or similar: Tc-PYP or Tc-HMDP) to evaluate the degree of cardiac uptake from 0 to 3 degrees.

Diagnostic Test: Proteinogram and serum immunoglobulins. Light chains free in serum -Freelite-. Immunofixation in serum and urine Analysis to rule out the presence of monoclonal protein in blood and urine.

Patients with confirmed ATTR type Cardiac Amyloidosis will undergo a study of mutations in the TTR gene

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Patients in whom Cardiac Amyloidosis is confirmed	Diagnostic test: Bone-cardiac scintigraphy; Patients with confirmed ATTR type CA will undergo a study of mutations in the TTR gene; Other Names: Laboratory test to rule out monoclonal protein
Group 2; Patients in whom Cardiac Amyloidosis is ruled out	Diagnostic test: Bone-cardiac scintigraphy; Patients with confirmed ATTR type CA will undergo a study of mutations in the TTR gene; Other Names: Laboratory test to rule out monoclonal protein

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Collaborators: Pfizer
• Investigators: Principal Investigator: Prado Salamanca-Bautista, MD, PhD, Hospital Universitario Virgen Macarena; Principal Investigator: Rocio Ruiz-Hueso, MD, Hospital Universitario Virgen Macarena

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): March 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Amyloidosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Proteostasis Deficiencies; Heart Failure; Amyloidosis; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal; Myeloma Proteins; Paraproteins
• Other Study ID Numbers: REGAMIC-1450-N-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No