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

Sponsor
University Hospital, Bordeaux
Study ID
NCT07677319
Status
Recruiting
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Conditions

  • Cardiac Surgery
  • Frailty
  • QALYs

Eligibility Criteria

Sex
ALL
Age
75 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Jun 30, 2026
Start date
Dec 3, 2025
Status verified
Jun 2026
Primary completion
Dec 3, 2028
Completion
Dec 3, 2028

Study Design

Enrollment
265 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Frail group
    Patients with Clinical Frailty Score CFS ≥ 4
  • Experimental: Non-frail group
    Patients with Clinical Frailty Score CFS \< 4

Primary Outcome Measure

Quality-Adjusted Life Years (QALYs) according to preoperative frailty status [ Time Frame: Month 12 ]

Central Contacts

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