FrailtySAGE-HeartNCT07677319
SAGE-Heart : Senior Assessment fraGility and Post-opErative QALYs 1 Year After Emergency HEART Surgery for Patients Aged 75 and Older
A study testing Phone Calls in people with Frailty and Cardiac Surgery, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frailty, Cardiac Surgery, QALYs
- What is being tested?
- Phone Calls
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2025to 3 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital, Bordeaux
Bordeaux, France, 33076
Simon CARRE, MD, 0556795679 ext. +33, simon.carre@chu-bordeaux.fr
About this study
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.
Read the detailed description
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.
- Conditions
- Frailty, Cardiac Surgery, QALYs
- Being tested
- Phone Calls
- Keywords
- Frailty, Elderly, Cardiac Surgery, Cardio-pulmonary Bypass, QALYs, Clinical Frailty Scale, EuroQol, postoperative
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone CallsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Frail group | Experimental | Patients with Clinical Frailty Score CFS ≥ 4 Receives: Other: Phone Calls |
| Non-frail group | Experimental | Patients with Clinical Frailty Score CFS < 4 Receives: Other: Phone Calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 12
Secondary outcomes (11)
Postoperative complications
Incidence of postoperative cardiac, respiratory, renal, infectious, and neurological complications during the first 28 postoperative days.
Measured: From surgery through,Day 28
All-cause mortality
All-cause mortality assessed during ICU stay, hospital stay, and at Month 3, Month 6, and Month 12.
Measured: Through Month 12
EQ-5D-5L Utility Index
Health-related quality of life assessed using the EQ-5D-5L utility index derived from the French value set
Measured: Baseline, Month 3, Month 6, and Month 12
Dialysis dependence
Dialysis dependence among participants not receiving chronic dialysis before surgery.
Measured: Month 3, Month 6, and Month 12
Length of intensive care unit stay
Duration of postoperative ICU stay.
Measured: From ICU admission to ICU discharge (assessed up to Day 28)
Length of hospital stay
Total postoperative hospital length of stay.
Measured: From surgery to hospital discharge
Hospital readmissions
Number of hospital readmissions since discharge, assessed at each follow-up visit.
Measured: Month 3, Month 6, and Month 12
Chronic postoperative pain
Presence of chronic pain related to cardiac surgery.
Measured: Month 3, Month 6, and Month 12
Analgesic consumption
Type of analgesic medication and frequency of use since the previous follow-up assessment.
Measured: Month 3, Month 6, and Month 12
Living situation
Living at home versus institutionalization during follow-up.
Measured: Month 3, Month 6, and Month 12
EQ-5D-5L visual analogue scale (EQ VAS)
Self-rated health status assessed using the EQ-5D-5L visual analogue scale (0-100).
Measured: Baseline, Month 3, Month 6, and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start3 Dec 2025
- Primary completion3 Dec 2028 (estimated)
- Study completion3 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon CARRE, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677319
- Sponsor's protocol ID
- CHUBX 2025/040
- Acronym
- SAGE-Heart
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAGE-Heart : Senior Assessment fraGility and Post-opErative QALYs 1 Year After Emergency HEART Surgery for Patients Aged 75 and Older
- ClinicalTrials.gov ID
- NCT07677319
- Acronym / sponsor ID
- SAGE-Heart / CHUBX 2025/040
- Conditions
- Frailty, Cardiac Surgery, QALYs
- Keywords
- Frailty, Elderly, Cardiac Surgery, Cardio-pulmonary Bypass, QALYs, Clinical Frailty Scale, EuroQol, postoperative
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 3 Dec 2028 (estimated)
- Study completion
- 3 Dec 2028 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frail group | Experimental | Other: Phone CallsPatients with Clinical Frailty Score CFS ≥ 4 |
| Non-frail group | Experimental | Other: Phone CallsPatients with Clinical Frailty Score CFS < 4 |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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) :
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone CallsPhone calls will be made at 3, 6, and 12 months to report quality of life scores (EuroQol EQ 5D-5L) and other postoperative data | Other | Frail group, Non-frail group |
Primary outcome
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.
11 secondary outcomes
Postoperative complications
Time frame: From surgery through,Day 28
All-cause mortality
Time frame: Through Month 12
EQ-5D-5L Utility Index
Time frame: Baseline, Month 3, Month 6, and Month 12
Dialysis dependence
Time frame: Month 3, Month 6, and Month 12
Length of intensive care unit stay
Time frame: From ICU admission to ICU discharge (assessed up to Day 28)
Length of hospital stay
Time frame: From surgery to hospital discharge
Hospital readmissions
Time frame: Month 3, Month 6, and Month 12
Chronic postoperative pain
Time frame: Month 3, Month 6, and Month 12
Analgesic consumption
Time frame: Month 3, Month 6, and Month 12
Living situation
Time frame: Month 3, Month 6, and Month 12
EQ-5D-5L visual analogue scale (EQ VAS)
Time frame: Baseline, Month 3, Month 6, and Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simon CARRE, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone Calls in people with Frailty and Cardiac Surgery, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon CARRE, MD (0556795679 ext. +33, simon.carre@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality-Adjusted Life Years (QALYs) according to preoperative frailty status (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.