Clinical trial NCT06092970: An Evaluation of Patient Reported Outcomes and Clinical Outcomes
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-Operative Complications in Cardiac Surgery
Lead sponsor: Renibus Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects who complete the Phase 3 REN-007 study are eligible to participate in the Extension Study.

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


Eligibility 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.

Primary outcomes:
measure: Evaluation
timeFrame: 12 Months Post-Cardiac Surgery
measure: Evaluation
timeFrame: 12 Months Post-Cardiac Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: San Francisco
country: United States
facility: Research Site
state: California
city: Stanford
country: United States
facility: Research Site
state: California
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Atlantis
country: United States
facility: Research Site
state: Florida
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Athens
country: United States
facility: Research Site
state: Georgia
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Fort Wayne
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Kansas City
country: United States
facility: Research Site
state: Kansas
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Lansing
country: United States
facility: Research Site
state: Michigan
city: Midland
country: United States
facility: Research Site
state: Michigan
city: Royal Oak
country: United States
facility: Research Site
state: Michigan
city: Rochester
country: United States
facility: Research Site
state: Minnesota
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Flushing
country: United States
facility: New York Presbyterian-Queens
state: New York
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
city: Kelowna
country: Canada
facility: Research Site
state: British Columbia
city: Saint John
country: Canada
facility: Research Site
state: New Brunswick
city: Saint John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Montréal
country: Canada
facility: Research Site
state: Quebec
city: Montréal
country: Canada
facility: Research Site
state: Quebec
city: Montréal
country: Canada
facility: Research Site
state: Quebec
city: Montréal
country: Canada
facility: Research Site
state: Quebec
city: Québec
country: Canada
facility: Research Site
state: Quebec
Study officials:
References: