An Evaluation of Patient Reported Outcomes and Clinical Outcomes

Clinical Protocol REN-007E - Extension Study: An Evaluation of Patient Reported Outcomes and Clinical Outcomes Through 12 Months Post-Cardiac Surgery in Subjects Enrolled in Study REN-007

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06092970

Enrollment

353

Registered

2023-10-23

Start date

2023-10-16

Completion date

2026-02-06

Last updated

2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Operative Complications in Cardiac Surgery

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

Interventions

DRUGRBT-1

Intravenous administration

DRUGPlacebo

Intravenous administration

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Evaluation	12 Months Post-Cardiac Surgery	To evaluate patient reported outcomes (PRO) using the EQ-5D questionnaire

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026