Cardiac Amyloid Biorepository (CARP)

March 3, 2024 updated by: Andrew Kolodziej

Cardiac Amyloidosis Research Program

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

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky
        • Principal Investigator:
          • Andrew Kolodziej, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients referred for or undergoing treatment for cardiac amyloidosis or receiving a right heart catheterization who are at least 18 years of age.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Biological specimens
Biological specimens taken from cardiovascular procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discover and quantify the concentration of novel diagnostic and prognostic biomarkers
Time Frame: 12/21/2021-12/31/2027
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrew Kolodziej

Investigators

  • Principal Investigator: Andrew R Kolodziej, MD, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2021

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 20, 2022

First Submitted That Met QC Criteria

August 25, 2022

First Posted (Actual)

August 30, 2022

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 73647

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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