400 Participants Needed

An Evaluation of Patient Reported Outcomes and Clinical Outcomes

Recruiting at 34 trial locations
JP
AR
Andre Lamy - McMaster Experts
Overseen ByAndre Lamy
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Renibus Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

Inclusion Criteria

Eligibility for the Extension Study is contingent upon having completed the REN-007 study.

Treatment Details

Participant Groups
2Treatment groups
Experimental Treatment
Group I: RBT-1Experimental Treatment1 Intervention
Patients undergoing CABG, valve, or combined CABG/valve surgery
Group II: PlaceboExperimental Treatment1 Intervention
Patients undergoing CABG, valve, or combined CABG/valve surgery

Find a Clinic Near You

Who Is Running the Clinical Trial?

Renibus Therapeutics, Inc.

Lead Sponsor

Trials
8
Recruited
1,200+