Registry of Patients with Suspected Amyloidosis in Heart Failure: Regamic
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Differential characteristics between two groups
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Differential characteristics between two groups
Time Frame: Up to two years
Number of biopsies performed between both groups.
Secondary Outcomes
- Prognostic differences between both groups(Up to two years)
- Prognostic differences between two groups(Up to Two years)