NCT Number: NCT07009340
Retrospective Observational Study of Patients Who Have Undergone Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery
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.
This study is active but is not currently recruiting participants.
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Heart Center Research, LLC, Huntsville, Alabama, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patient completed REN-004
- Patient has at least 1 year of follow documentation post-discharge
Exclusion criteria
- Patient enrolled in a clinical trial within 1-year post-discharge from REN-004
Treatment and study plan
Primary outcomes
-
Post-discharge outcomes for patients enrolled in REN-004 from one study center
Time frame: 1 year
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
Secondary outcomes
-
Total estimated cost of in hospital and post-discharge
Time frame: 1 year
Sponsors and collaborators
Lead sponsor
Renibus Therapeutics, Inc.
Industry
Registry information
Official study title
Retrospective Observational Study of Patients Who Have Undergone Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery: Post-discharge Follow-up of Patients From REN-004 Clinical Trial
Important dates
- Study start
- 2023
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Jun 6, 2025
- Registry last updated
- Jun 13, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.