NCT05521503

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Dec 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Dec 2021Dec 2030

Study Start

First participant enrolled

December 21, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

9 years

First QC Date

August 20, 2022

Last Update Submit

January 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Discover and quantify the concentration of novel diagnostic and prognostic biomarkers

    Use biospecimens procured from patients with cardiac conditions to identify diagnostic surrogate biomarkers using discovery proteomics. In Cardiac Amyloidosis, the serum levels will be compared between confirmed ATTR and non-ATTR heart failure patients and a diagnostic threshold will be established. The research aims to advance understanding of cardiac diseases and to support the development of improved therapies.

    12/21/2021-12/31/2030

Study Arms (1)

Biological specimens

Biological specimens taken from cardiovascular procedures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing evaluation of a cardiac condition or receiving a right heart catheterization with biopsy clinically indicated who are at least 18 years of age.

You may qualify if:

  • All patients undergoing evaluation of a cardiac condition or receiving a right heart catheterization with biopsy clinically indicated who are at least 18 years of age.

You may not qualify if:

  • Patients without a cardiovascular or amyloidosis diagnosis, under 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

During this study, tissue samples (blood, urine and/or myocardial tissue) will be used to help identify trends in biomarkers and other information for patients with Cardiac Amyloidosis and other Cardiovascular conditions. No clinically important information that could be used by the subject will be identified. Therefore, the results of these studies will not be shared with the subjects.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Kenneth S Campbell, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth S Campbell, PhD

CONTACT

Jennifer Isaacs, MS, MS

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 20, 2022

First Posted

August 30, 2022

Study Start

December 21, 2021

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations