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
1 other identifier
observational
379
2 countries
39
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Typical duration for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2023
CompletedStudy Start
First participant enrolled
October 16, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
August 1, 2025
July 1, 2025
2.7 years
October 3, 2023
July 31, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Evaluation
To evaluate patient reported outcomes (PRO) using the EQ-5D questionnaire
12 Months Post-Cardiac Surgery
Evaluation
The number of subjects with the following clinical outcomes will be reported Clinical Outcomes: * Chronic kidney disease (CKD) - new diagnosis * Acute kidney injury (AKI) or CKD requiring dialysis * Atrial fibrillation - new-onset * Death * Myocardial infarction (MI) * Non-fatal cardiac arrest * Readmission to hospital * Reoperation for coronary artery bypass graft (CABG) and/or valve dysfunction * Stroke
12 Months Post-Cardiac Surgery
Study Arms (2)
RBT-1
Patients undergoing CABG, valve, or combined CABG/valve surgery
Placebo
Patients undergoing CABG, valve, or combined CABG/valve surgery
Interventions
Eligibility Criteria
All subjects who complete the Phase 3 REN-007 study are eligible to participate in the Extension Study.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Research Site
Huntsville, Alabama, 35801, United States
Research Site
San Francisco, California, 94107, United States
Research Site
Stanford, California, 94305, United States
Research Site
Washington D.C., District of Columbia, 20010, United States
Research Site
Atlantis, Florida, 33462, United States
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Gainesville, Florida, 32608, United States
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Athens, Georgia, 30606, United States
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Atlanta, Georgia, 30342, United States
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Fort Wayne, Indiana, 46804, United States
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Indianapolis, Indiana, 46202, United States
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Indianapolis, Indiana, 46237, United States
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Kansas City, Kansas, 66160, United States
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Boston, Massachusetts, 02115, United States
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Ann Arbor, Michigan, 48109, United States
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Lansing, Michigan, 48879, United States
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Midland, Michigan, 48670, United States
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Royal Oak, Michigan, 48073, United States
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Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63310, United States
New York Presbyterian-Queens
Flushing, New York, 11355, United States
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Raleigh, North Carolina, 27610, United States
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Winston-Salem, North Carolina, 27157, United States
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Cleveland, Ohio, 44106, United States
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Toledo, Ohio, 43606, United States
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Nashville, Tennessee, 37203, United States
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Dallas, Texas, 75390, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78229, United States
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Charlottesville, Virginia, 22903, United States
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Kelowna, British Columbia, V1Y 0C5, Canada
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Saint John, New Brunswick, E2L 4L2, Canada
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Hamilton, Ontario, L8L 2X2, Canada
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Kingston, Ontario, K7L 2V7, Canada
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Montreal, Quebec, H1T 1C8, Canada
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Montreal, Quebec, H2X 0C1, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Montreal, Quebec, H4J 1C5, Canada
Research Site
Québec, Quebec, G1V 4G5, Canada
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2023
First Posted
October 23, 2023
Study Start
October 16, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
August 1, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share