Retrospective Observational Study of Patients Who Have Undergone Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery

NCT07009340 | Active Not Recruiting

• 1 other identifier: RT-RBT1-RWE01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

This study is a retrospective chart abstraction for subjects who were enrolled in REN-004. As a retrospective study, all data will be abstracted from the medical records.

Conditions

Post-discharge Outcomes

Outcome Measures

Primary Outcomes (1)

• Post-discharge outcomes for patients enrolled in REN-004 from one study center

  Readmission for any reason Rehospitalization related to procedure/valve/heart failure Contacts with HCP post discharge (any HCP) PCP (if available) All tests and procedures post discharge Medications Chronic kidney disease (CKD) - new diagnosis Acute kidney injury (AKI) requiring dialysis Chronic Kidney disease (CKD) requiring dialysis Atrial fibrillation - new-onset Myocardial infarction (MI) Non-fatal cardiac arrest Reoperation for coronary artery bypass graft (CABG) Reoperation for valve dysfunction Stroke Death from any cause MACCE Death from any cause, repeat revascularization (CABG or PCI), non-fatal MI, and stroke

  1 year

Secondary Outcomes (1)

• Total estimated cost of in hospital and post-discharge

  1 year

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

Patients who completed REN-004 and have at least 1 year of follow documentation post-discharge

You may qualify if:

• Patient completed REN-004
• Patient has at least 1 year of follow documentation post-discharge

You may not qualify if:

• Patient enrolled in a clinical trial within 1-year post-discharge from REN-004

Sponsors & Collaborators

• Renibus Therapeutics, Inc.: lead

Study Sites (4)

Heart Center Research, LLC

Huntsville, Alabama, 35801, United States

Location

Lutheran Medical Center

Fort Wayne, Indiana, 46804, United States

Location

My Michigan Medical Center

Midland, Michigan, 48670, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75399, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: November 18, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)