SAGE-Heart : Senior Assessment fraGility and Post-opErative QALYs 1 Year After Emergency HEART Surgery for Patients Aged 75 and Older

NCT07677319 | Recruiting

• 1 other identifier: CHUBX 2025/040
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis is that the preoperative Clinical Frailty Score (CFS) is a predictive factor for a loss in quality-adjusted life years (QALYs) one year after emergency cardiac surgery under cardiopulmonary bypass (CPB) in patients aged 75 years and older.

Conditions

Frailty; Cardiac Surgery; QALYs

Keywords

Frailty; Elderly; Cardiac Surgery; Cardio-pulmonary Bypass; QALYs; Clinical Frailty Scale; EuroQol, postoperative

Outcome Measures

Primary Outcomes (1)

• Quality-Adjusted Life Years (QALYs) according to preoperative frailty status

  QALYs over the 12-month follow-up will be estimated from EQ-5D-5L utility scores collected at baseline, Month 3, Month 6, and Month 12 together with survival data, and compared between participants with preoperative frailty (Clinical Frailty Scale ≥4) and those without frailty (Clinical Frailty Scale \<4), with adjustment for EuroSCORE II.

  Month 12

Secondary Outcomes (11)

• Postoperative complications

  From surgery through,Day 28

• All-cause mortality

  Through Month 12

• EQ-5D-5L Utility Index

  Baseline, Month 3, Month 6, and Month 12

• Dialysis dependence

  Month 3, Month 6, and Month 12

• Length of intensive care unit stay

  From ICU admission to ICU discharge (assessed up to Day 28)

Study Arms (2)

Frail group

EXPERIMENTAL

Patients with Clinical Frailty Score CFS ≥ 4

Other: Phone Calls

Non-frail group

EXPERIMENTAL

Patients with Clinical Frailty Score CFS \< 4

Other: Phone Calls

Interventions

Phone Calls OTHER

Phone calls will be made at 3, 6, and 12 months to report quality of life scores (EuroQol EQ 5D-5L) and other postoperative data

Frail group; Non-frail group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients aged ≥ 75 years who are affiliated with or beneficiaries of a social security scheme and undergoing emergency cardiac surgery under cardiopulmonary bypass, either immediate or urgent (relative) :
• Immediate emergency surgery: intervention performed before the start of the next working day following the decision to operate,
• Urgent (relative) emergency surgery: patients not admitted electively for surgery but requiring an intervention during the current hospital stay for medical reasons, and who cannot be discharged without undergoing a definitive procedure

You may not qualify if:

• Patients requiring preoperative cardiopulmonary resuscitation
• Scheduled (elective) surgery
• Lack of informed consent
• Individuals under legal guardianship or judicial protection
• Individuals participating in another interventional research protocol

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Hospital, Bordeaux

Bordeaux, France, 33076, France

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon CARRE, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon CARRE, MD

CONTACT

0556795679; simon.carre@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 30, 2026
• Study Start: December 3, 2025
• Primary Completion (Estimated): December 3, 2028
• Study Completion (Estimated): December 3, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)