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Evaluating patient and clinical outcomes after cardiac surgery

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

Observational Renibus Therapeutics, Inc. · NCT06092970

This study looks at how people feel and their health after heart surgery to see how well they recover over a year.

Quick facts

Study typeObservational
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorRenibus Therapeutics, Inc. Industry-sponsored
Locations39 sites (Huntsville, Alabama and 38 other locations)
Trial IDNCT06092970 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess patient-reported outcomes and clinical outcomes in individuals who have undergone cardiac surgery. Participants will complete the EQ-5D questionnaire to evaluate their quality of life and other health-related metrics over a 12-month period following surgery. The study will include data from patients who previously participated in the REN-007 study, allowing for a comprehensive analysis of post-operative recovery and complications. The focus is on understanding both subjective and objective measures of health outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals who have completed the REN-007 study and have undergone cardiac surgery.

Not a fit: Patients who did not complete the REN-007 study or who become pregnant during that study will not benefit from this extension study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the recovery process after cardiac surgery, potentially leading to improved patient care and management strategies.

How similar studies have performed: Other studies evaluating patient-reported outcomes in surgical populations have shown success, indicating that this approach is both relevant and potentially beneficial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Huntsville, Alabama and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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Conditions Post-Operative Complications in Cardiac Surgery
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.