Registry of Patients with Suspected Amyloidosis in Heart Failure

NCT05176548 | Active Not Recruiting

• 1 other identifier: REGAMIC-1450-N-21
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Differential characteristics between two groups

  Number of biopsies performed between both groups.

  Up to two years

Secondary Outcomes (2)

• Prognostic differences between both groups

  Up to two years

• Prognostic differences between two groups

  Up to Two years

Study Arms (2)

Group 1

Patients in whom Cardiac Amyloidosis is confirmed

Diagnostic Test: Bone-cardiac scintigraphy

Group 2

Patients in whom Cardiac Amyloidosis is ruled out

Diagnostic Test: Bone-cardiac scintigraphy

Interventions

Bone-cardiac scintigraphy DIAGNOSTIC_TEST

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

Also known as: Laboratory test to rule out monoclonal protein

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• Refusal to participate in the registry

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead
• Pfizer: collaborator

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, SEVILLA, 41071, Spain

Location

MeSH Terms

Conditions

Heart Failure; Amyloidosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Prado Salamanca-Bautista, MD, PhD

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

• Rocio Ruiz-Hueso, MD

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: January 4, 2022
• Study Start: January 15, 2022
• Primary Completion: March 31, 2024
• Study Completion: December 31, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)