An Evaluation of Patient Reported Outcomes and Clinical Outcomes

Running, not enrolling · Has a placebo group

Conditions studied: Post-Operative Complications in Cardiac Surgery

In brief

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

Key facts

Study ID

NCT06092970

Run by

Renibus Therapeutics, Inc.

People needed

379

Starts

2023-10-16

Expected to finish

2026-06-30

Last updated by the study team

2025-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have completed the REN-007 study to be eligible to participate in the Extension Study.

You may not qualify if…

• 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.

Where it is running

• Research Site — Huntsville, Alabama, United States
• Research Site — San Francisco, California, United States
• Research Site — Stanford, California, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Atlantis, Florida, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Athens, Georgia, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Fort Wayne, Indiana, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Kansas City, Kansas, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Lansing, Michigan, United States
• Research Site — Midland, Michigan, United States
• Research Site — Royal Oak, Michigan, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — St Louis, Missouri, United States
• New York Presbyterian-Queens — Flushing, New York, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Toledo, Ohio, United States
• Research Site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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