NCT07895719 Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
| NCT ID | NCT07895719 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital of Ferrara |
| Condition | Aortic Stenosis Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2026-11-04 |
| Primary Completion | 2029-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2026-11-04 with a primary completion date of 2029-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Elisabetta Tonet, MD
PRINCIPAL INVESTIGATOR
University Hospital of Ferrara
Frequently Asked Questions
Who can join the NCT07895719 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Aortic Stenosis Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07895719 currently recruiting?
Yes, NCT07895719 is actively recruiting participants. Contact the research team at ldlvnc@unife.it for enrollment information.
Where is the NCT07895719 trial being conducted?
This trial is being conducted at Ferrara, Italy.
Who is sponsoring the NCT07895719 clinical trial?
NCT07895719 is sponsored by University Hospital of Ferrara. The principal investigator is Elisabetta Tonet, MD at University Hospital of Ferrara. The trial plans to enroll 450 participants.