Exercise and nutrition support before and after TAVI for older adults with aortic stenosis
Official title: Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Run by University Hospital of Ferrara · NCT07895719 · Data updated 2026-11-12
This trial tests whether a personalized exercise program plus protein and iron supplements before and after a transcatheter valve replacement can help older adults with aortic stenosis recover better than standard care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 75 Years and up |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | University Hospital of Ferrara Academic / other |
| Locations | 1 site (Ferrara, FE) |
| Status | Recruiting |
| Started | November 4, 2026 |
| Main results expected | November 30, 2029 |
| Study ends | November 30, 2031 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07895719 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 75 years and older with severe symptomatic aortic stenosis undergoing TAVI who have reduced physical performance (SPPB < 10) or impaired nutrition (MNA-SF < 12).
✕Probably not a fit
Patients without physical frailty or malnutrition, or those unable to adhere to an exercise and supplementation program, may not realize benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, randomized trial enrolls about 450 patients aged 75 and older with severe symptomatic aortic stenosis and reduced physical performance or nutrition. Participants are assigned to standard care or a multidomain rehabilitation that combines supervised and home-based exercise with individualized nutrition coaching and oral protein/iron supplementation, starting before TAVI and continuing for three months after. The study aims to determine if improving physical performance and nutritional status can lead to better functional outcomes and lower health care utilization after the procedure. It uses blinded adjudication of clinical events in an open-label design to compare outcomes between groups. Eligible patients have confirmed TAVI indications and measurable frailty or malnutrition, while those with limited life expectancy or inability to participate in exercise are excluded.
Why it matters
Potential benefit: If successful, patients may experience better physical recovery, improved quality of life, and fewer hospital readmissions after TAVI.
How similar studies have gone: Prior research supports multidomain rehab approaches in similar surgical populations, but this specific pre- and post-TAVI nutrition-plus-exercise strategy is novel in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Non-cardiovascular co-morbidity reducing life expectancy to \<1 year * Any factor precluding 1-year follow-up * Extra-cardiovascular condition precluding participation in the exercise training sessions * Refusal or inability to provide written informed consent.
Where it's running
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Azienda Ospedaliero Universitaria di Ferrara
Ferrara, Fe, Italy Recruiting
Study contacts
- Principal investigator: Elisabetta Tonet, MD — University Hospital of Ferrara
- Study coordinator: Veronica Lodolini
- Email: ldlvnc@unife.it
- Phone: 0532236450
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.