Clinical trial NCT05176548: Registry of Patients with Suspected Amyloidosis in Heart Failure
Official title: Registry of Patients with Suspected Amyloidosis in Heart Failure: Regamic
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Failure
Keywords: Amyloidosis
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2022-01-04
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differential characteristics between two groups
timeFrame: Up to two years
Secondary outcomes:
measure: Prognostic differences between both groups
timeFrame: Up to two years
measure: Prognostic differences between two groups
timeFrame: Up to Two years
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Prado Salamanca-Bautista, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Virgen Macarena
name: Rocio Ruiz-Hueso, MD
role: PRINCIPAL_INVESTIGATOR
References: