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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Sponsor: University Hospital of Ferrara
Summary
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.
Key Details
Gender
All
Age Range
75 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2026-11-04
Completion Date
2031-11-30
Last Updated
2026-10-27
Healthy Volunteers
No
Interventions
Personalized Multidomain Exercise Program
Participants assigned to the multidomain intervention will receive a personalized exercise training program beginning before transcatheter aortic valve implantation and continuing for three months after the procedure. The program includes five supervised exercise sessions, two before and three after the procedure, together with a structured home-based exercise program. Exercise includes walking, mobility exercises, sit-to-stand exercises, balance training, and progressive functional strengthening. Exercise intensity and progression will be individualized according to symptoms, physical performance, clinical condition, and exercise tolerance.
Oral Protein and Iron Nutritional Supplementation
Participants assigned to the multidomain intervention will receive individualized nutritional counseling and daily oral nutritional supplementation containing protein and iron. Supplementation will start after randomization, before transcatheter aortic valve implantation, and will continue for three months after the procedure. The nutritional intervention will be adapted according to baseline nutritional status, body weight, appetite, renal function, clinical condition, and tolerance. Adherence and tolerability will be monitored throughout the intervention period.
Usual Care
Participants assigned to the control group will receive standard care according to current clinical practice, including transcatheter aortic valve implantation, guideline-directed medical management, routine follow-up, and general advice regarding physical activity and a balanced diet. No structured study-driven exercise program or protocol-mandated nutritional supplementation will be provided.
Locations (1)
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, FE, Italy