An interventional study of Personalized Multidomain Exercise Program and Oral Protein and Iron Nutritional Supplementation in Aortic Stenosis Disease, Aortic Stenosis Symptomatic and Aortic Stenosis, sponsored by University Hospital of Ferrara. Not yet recruiting at 1 site in Italy. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by University Hospital of Ferrara · Not applicable, Interventional, and Treatment
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.
Severe symptomatic aortic stenosis mainly affects older adults and is frequently associated with reduced physical performance, frailty, sarcopenia, and impaired nutritional status. Although transcatheter aortic valve implantation effectively treats the valvular obstruction, a substantial proportion of older patients experience incomplete functional recovery, persistent disability, reduced quality of life, or hospital readmission after an otherwise successful procedure.
Reduced physical performance and impaired nutritional status are clinically relevant because they are common, strongly associated with adverse outcomes, and potentially modifiable. The IRON-TAVI trial has therefore been designed to test whether a structured multidomain intervention targeting these two domains can improve outcomes in older patients undergoing transcatheter aortic valve implantation.
The study is a prospective, randomized, multicenter, open-label superiority trial with blinded adjudication of clinical events. Approximately 450 patients aged 75 years or older with severe symptomatic aortic stenosis and a Heart Team indication to transcatheter aortic valve implantation will be enrolled. Eligible patients must also have reduced physical performance, defined by a Short Physical Performance Battery score below 10, and/or impaired nutritional status, defined by a Mini Nutritional Assessment Short Form score below 12.
After confirmation of eligibility and written informed consent, participants will be randomly assigned in a one-to-one ratio to either standard care or the multidomain intervention in addition to standard care. Randomization will be centralized and stratified by participating center, sex, baseline physical performance, and baseline nutritional status.
Patients assigned to the multidomain intervention will receive a personalized exercise and nutritional program beginning before transcatheter aortic valve implantation and continuing for three months after the procedure. The exercise component includes five supervised sessions, two before and three after the valve procedure, together with an individualized home-based exercise program. Exercise activities include walking, mobility exercises, sit-to-stand exercises, balance training, and progressive functional strengthening. Exercise intensity and progression are adapted to the patient's clinical condition, symptoms, physical performance, and tolerance.
The nutritional component includes individualized dietary counseling and daily oral supplementation containing protein and iron. The intervention is intended to support adequate nutritional intake, preserve or improve muscle function, and promote functional recovery before and after transcatheter aortic valve implantation. Adherence, tolerance, and safety of both the exercise and nutritional components will be monitored throughout the intervention period.
Patients assigned to the control group will receive standard care according to current clinical practice, including transcatheter aortic valve implantation, medical therapy, routine advice on physical activity and diet, and standard follow-up. No structured study-driven exercise or nutritional supplementation program will be provided in the control group.
All participants will be followed for 12 months after randomization. Clinical outcomes will be adjudicated by an independent committee blinded to treatment allocation. The primary clinical outcome is the one-year occurrence of death from any cause, stroke, or hospital readmission for cardiovascular causes. Secondary assessments include mortality, cardiovascular events, hospital readmission, physical performance, nutritional status, sarcopenia-related measures, and health-related quality of life.
1,007 studies on the registry are indexed under Aortic Valve Stenosis; 284 are open to participants now.
This study's planned enrollment of 450 is above the median of 120 across 537 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →University Hospital of Ferrara is the lead sponsor of 114 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must fulfill all the following inclusion criteria to be eligible for the study:
1. Age ≥75 years 2. Symptomatic aortic stenosis 3. Indication to transcatheter aortic valve implantation (TAVI) confirmed by the Heart Team 4. 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 5. Written informed consent
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded from the study:
1. Non-cardiovascular co-morbidity reducing life expectancy to \<1 year 2. Any factor precluding 1-year follow-up 3. Extra-cardiovascular condition precluding participation in the exercise training sessions 4. Refusal or inability to provide written informed consent.
Participants will receive standard care plus a personalized multidomain program including supervised exercise sessions before and after transcatheter aortic valve implantation, a structured home-based exercise program, individualized nutritional counseling, and daily oral protein and iron supplementation. The intervention starts before the procedure and continues for three months after transcatheter aortic valve implantation.
Behavioral: Personalized Multidomain Exercise Program · Dietary Supplement: Oral Protein and Iron Nutritional Supplementation
Participants 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.
Other: Usual Care
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.
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.
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.
Time to First All-Cause Death, Stroke, or Hospital Readmission for Cardiovascular Causes
Composite clinical outcome defined as the time from randomization to the first occurrence of all-cause death, stroke, or hospital readmission for cardiovascular causes. Clinical events will be independently adjudicated by a blinded Clinical Event Committee according to Valve Academic Research Consortium-3 definitions whenever applicable.
Time frame: From randomization through 12 months
All-cause death
Clinical outcome defined as the time from randomization to the first occurrence of all-cause death.
Time frame: From randomization through 12 months
Cardiovascular death
Clinical outcome defined as the time from randomization to the first occurrence of cardiovascular death.
Time frame: From randomization through 12 months
Stroke
Clinical outcome defined as the time from randomization to the first occurrence of stroke.
Time frame: From randomization through 12 months
Myocardial infarction
Clinical outcome defined as the time from randomization to the first occurrence of myocardial infarction.
Time frame: From randomization through 12 months
Hospital readmission for heart failure
Clinical outcome defined as the time from randomization to the first occurrence of hospital readmission for heart failure
Time frame: From randomization through 12 months
Hospital readmission for cardiovascular cause
Clinical outcome defined as the time from randomization to the first occurrence of hospital readmission for cardiovascular cause
Time frame: From randomization through 12 months
Hospital readmission for any cause
Clinical outcome defined as the time from randomization to the first occurrence of hospital readmission for any cause
Time frame: From randomization through 12 months
Primary safety endpoint
The primary safety endpoint is the cumulative occurrence of adverse events related to exercise training or dietary supplementation. These include, but are not limited to, angina resurgence, heart failure worsening, bleeding, falls or traumatism related to exercise training, and worsening renal function or other clinically relevant adverse effects related to dietary supplementation.
Time frame: From randomization through 12 months
Plan to share: Undecided — Individual participant data sharing is not currently planned. However, reasonable requests for access to de-identified study data may be considered after publication of the main study results. Any such request will be evaluated by the Steering Committee on a case-by-case basis, taking into account the scientific rationale, proposed analyses, data protection requirements, participant confidentiality, and applicable regulatory and institutional policies.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2029, 36 months later.
Of 174 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's planned 36 months is close to that.
Counting every sponsor, half of 277 studies reached it within 33 months; a quarter within 19 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital of Ferrara →