An Evaluation of Patient Reported Outcomes and Clinical Outcomes

Renibus Therapeutics

Status: Active, not recruiting

Conditions: Post-Operative Complications in Cardiac Surgery

Treatments: Drug: Placebo; Drug: RBT-1

Study type: Observational

Funder types: Industry

Identifiers

NCT06092970

REN-007E

Details and patient eligibility

About

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

Enrollment: 379 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

379 participants in 2 patient groups

RBT-1

Description:

Patients undergoing CABG, valve, or combined CABG/valve surgery

Treatment:

Drug: RBT-1

Placebo

Description:

Patients undergoing CABG, valve, or combined CABG/valve surgery

Treatment:

Drug: Placebo