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NCT Number: NCT07677319

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

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.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Bordeaux

Bordeaux, France, 33076

Location status: Recruiting

Location contact

Simon CARRE, MD

CONTACT

[email protected]

0556795679 ext. +33

About this study

The advancement of structural cardiology, particularly with percutaneous valve interventions, offers new treatment options without the need for cardiopulmonary bypass (CPB). Despite an increase in the use of these techniques, some studies highlight a notable rise in CPB usage in patients aged 80 and over, from 13.8% in 2013 to 20.5% in 2022. In France, the population aged 85 and above is expected to triple by 2050, meaning more elderly patients will be eligible for CPB cardiac surgery. Several global studies have examined the outcomes of older individuals undergoing CPB cardiac surgery. While EuroSCORE II and STS scores are effective in predicting short-term mortality, they lack accuracy in predicting long-term mortality, particularly in frail patients, and do not assess quality of life. New tools to evaluate frailty, such as the Clinical Frailty Scale (CFS), are now used in preoperative assessments for planned cardiac interventions. Identifying frail elderly patients early is crucial for improving patient and family information on care plans, especially in high-risk surgeries. Even in emergencies, patients must remain involved in their health decisions, and multidisciplinary collaboration is vital for improving postoperative recovery and quality of life.

Data will be collected :

  • Preoperative: During the anesthesia consultation: Calculation of the CFS (frailty assessment = CFS ≥ 4) EuroQoL 5D-5L (quality of life, with the index calculated with the French value set of the EuroQol), and routine care (renal function: urea, creatinine, albumin levels).
  • Postoperative (ICU and hospital): Collection of complication incidence, mortality (all causes and LATA-related).
  • Follow-up (by phone at 3, 6, and 12 months): CFS and EuroQoL scores, prevalence of chronic pain and analgesic use, dialysis dependency, accommodation status, readmission rates, and death date if applicable.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients requiring preoperative cardiopulmonary resuscitation
  • Scheduled (elective) surgery
  • Lack of informed consent
  • Impaired consciousness at the time of inclusion (defined by a Glasgow Coma Scale score < 15)
  • Individuals under legal guardianship or judicial protection
  • Individuals participating in another interventional research protocol

Treatment and study plan

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

Primary outcomes

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

    Time frame: Month 12

    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.

Secondary outcomes

  1. Postoperative complications

    Time frame: From surgery through,Day 28

    Incidence of postoperative cardiac, respiratory, renal, infectious, and neurological complications during the first 28 postoperative days.

  2. All-cause mortality

    Time frame: Through Month 12

    All-cause mortality assessed during ICU stay, hospital stay, and at Month 3, Month 6, and Month 12.

  3. EQ-5D-5L Utility Index

    Time frame: Baseline, Month 3, Month 6, and Month 12

    Health-related quality of life assessed using the EQ-5D-5L utility index derived from the French value set

  4. Dialysis dependence

    Time frame: Month 3, Month 6, and Month 12

    Dialysis dependence among participants not receiving chronic dialysis before surgery.

  5. Length of intensive care unit stay

    Time frame: From ICU admission to ICU discharge (assessed up to Day 28)

    Duration of postoperative ICU stay.

  6. Length of hospital stay

    Time frame: From surgery to hospital discharge

    Total postoperative hospital length of stay.

  7. Hospital readmissions

    Time frame: Month 3, Month 6, and Month 12

    Number of hospital readmissions since discharge, assessed at each follow-up visit.

  8. Chronic postoperative pain

    Time frame: Month 3, Month 6, and Month 12

    Presence of chronic pain related to cardiac surgery.

  9. Analgesic consumption

    Time frame: Month 3, Month 6, and Month 12

    Type of analgesic medication and frequency of use since the previous follow-up assessment.

  10. Living situation

    Time frame: Month 3, Month 6, and Month 12

    Living at home versus institutionalization during follow-up.

  11. EQ-5D-5L visual analogue scale (EQ VAS)

    Time frame: Baseline, Month 3, Month 6, and Month 12

    Self-rated health status assessed using the EQ-5D-5L visual analogue scale (0-100).

Study contacts

Contact information is provided by the study sponsor or research team.

Simon CARRE, MD

CONTACT

[email protected]

0556795679 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: SAGE-Heart

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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