An Evaluation of Patient Reported Outcomes and Clinical Outcomes
Recruiting
- Conditions
- Post-Operative Complications in Cardiac Surgery
- Interventions
- Drug: Placebo
- Registration Number
- NCT06092970
- Lead Sponsor
- Renibus Therapeutics, Inc.
- Brief Summary
This extension study is being conducted to assess the following objectives through 12 months post-cardiac surgery:
* Patient reported outcomes (PRO), using the EQ-5D questionnaire
* Clinical outcomes
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- Subjects must have completed the REN-007 study to be eligible to participate in the Extension Study.
Exclusion Criteria
- Subjects who did not complete the REN-007 study are not eligible to participate in the Extension Study.
- Female subjects who become pregnant during the REN-007 study are not eligible to participate in the Extension Study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Placebo Placebo Patients undergoing CABG, valve, or combined CABG/valve surgery RBT-1 RBT-1 Patients undergoing CABG, valve, or combined CABG/valve surgery
- Primary Outcome Measures
Name Time Method Evaluation 12 Months Post-Cardiac Surgery The number of subjects with the following clinical outcomes will be reported
Clinical Outcomes:
* Chronic kidney disease (CKD) - new diagnosis
* Acute kidney injury (AKI) or CKD requiring dialysis
* Atrial fibrillation - new-onset
* Death
* Myocardial infarction (MI)
* Non-fatal cardiac arrest
* Readmission to hospital
* Reoperation for coronary artery bypass graft (CABG) and/or valve dysfunction
* Stroke
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Research Site
🇨🇦Québec, Quebec, Canada
New York Presbyterian-Queens
🇺🇸Flushing, New York, United States