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NCT05521503 Clinical Trial

Cardiac Amyloid Biorepository

Cardiac Amyloidosis Clinical Trial

— CARP  

Official title:
Cardiac Amyloidosis Research Program

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05521503
Other study ID # 73647
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 21, 2021
Est. completion date December 2027

Study information
Verified date March 2024
Source University of Kentucky
Contact Andrew R Kolodziej, MD
Phone (859) 562-0902
Email andrew.kolodziej@uky.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Use samples procured from patients to improve understanding of molecular, cellular, and tissue-level processes produced by cardiac amyloidosis and therapeutic interventions.

Description:

This is a prospective study enrolling patients referred for or undergoing cardiac amyloidosis or cardiovascular treatment at the University of Kentucky. The study aims to facilitate the discovery of novel diagnostic biomarkers and therapeutic targets and improve the pathophysiological understanding of cardiac amyloidosis.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients undergoing treatment for cardiac amyloidosis or receiving a right heart catheterization who are at least 18 years of age. Exclusion Criteria: - Patients without a cardiovascular or amyloidosis diagnosis, under 18 years of age.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (1)
Lead Sponsor Collaborator
Andrew Kolodziej

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Discover and quantify the concentration of novel diagnostic and prognostic biomarkers Use biospecimens procured from patients with cardiac amyloidosis to identify diagnostic surrogate biomarkers using discovery proteomics. The serum levels will be compared between confirmed ATTR and non-ATTR heart failure patients and a diagnostic threshold will be established. 12/21/2021-12/31/2027
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