Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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- Who runs it
- University Hospital of Ferrara
- Trial code
- NCT07895719
- Record updated
- 5 November 2026
- Original description
he IRON-TAVI trial is a prospective, randomized, multicenter study evaluating whether a multidomain rehabilitation program can improve outcomes in older patients undergoing transcatheter aortic valve implantation for severe symptomatic aortic stenosis.Read full original descriptionShow less
he IRON-TAVI trial is a prospective, randomized, multicenter study evaluating whether a multidomain rehabilitation program can improve outcomes in older patients undergoing transcatheter aortic valve implantation for severe symptomatic aortic stenosis.
The study will enroll approximately 450 patients aged 75 years or older who have reduced physical performance and/or impaired nutritional status. Participants will be randomly assigned in a one-to-one ratio to either standard care or a multidomain intervention in addition to standard care.
The multidomain intervention includes a personalized exercise program, combining supervised sessions before and after transcatheter aortic valve implantation with home-based exercises, together with individualized nutritional counseling and oral supplementation containing protein and iron. The intervention starts before the valve procedure and continues during the first three months after the procedure.
The study will assess whether this strategy improves clinical outcomes, physical performance, nutritional status, and quality of life compared with standard care alone. The main outcome will be the occurrence within one year of death from any cause, stroke, or hospital readmission for cardiovascular causes.
Inclusion: Age ≥75 years; Symptomatic aortic stenosis; Indication to transcatheter aortic valve implantation (TAVI) confirmed by the Heart Team; Reduced physical performance defined as Short Physical Performance Battery (SPPB) score <10 and/or poor nutritional status defined as Mini Nutritional Assessment Short Form (MNA-SF) score <12; Written informed consent.
Exclusion: Extra-cardiovascular condition precluding participation in the exercise training sessions; Non-cardiovascular co-morbidity reducing life expectancy to <1 year; Any factor precluding 1-year follow-up; Refusal or inability to provide written informed consent.