Aortic Stenosis DiseaseIRON-TAVINCT07895719
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
A study testing Personalized Multidomain Exercise Program and Oral Protein and Iron Nutritional Supplementation in people with Aortic Stenosis Disease and Aortic Stenosis Symptomatic, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Stenosis Disease, Aortic Stenosis Symptomatic, Aortic Stenosis
- What is being tested?
- Personalized Multidomain Exercise Program and Oral Protein and Iron Nutritional Supplementation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteItaly
- Study dates
- 4 Nov 2026to 30 Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, FE
Elisabetta Tonet, 0532237227 ext. +39, tonet.elisabetta@gmail.com
About this study
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Personalized Multidomain Exercise Program, Oral Protein and Iron Nutritional Supplementation, Usual Care
- Keywords
- aortic stenosis, prehabilitation, cardiac rehabilitation, transcatheter aortic valve implantation
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Multidomain Exercise ProgramBehavioural
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 SupplementationDietary supplement
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Multidomain intervention | Experimental | 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. Receives: Behavioral: Personalized Multidomain Exercise Program; Dietary Supplement: Oral Protein and Iron Nutritional Supplementation |
| Standard of care | Other | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization through 12 months
Secondary outcomes (7)
All-cause death
Clinical outcome defined as the time from randomization to the first occurrence of all-cause death.
Measured: From randomization through 12 months
Cardiovascular death
Clinical outcome defined as the time from randomization to the first occurrence of cardiovascular death.
Measured: From randomization through 12 months
Stroke
Clinical outcome defined as the time from randomization to the first occurrence of stroke.
Measured: From randomization through 12 months
Myocardial infarction
Clinical outcome defined as the time from randomization to the first occurrence of myocardial infarction.
Measured: 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
Measured: 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
Measured: 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
Measured: From randomization through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start4 Nov 2026 (estimated)
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a one-to-one ratio to two parallel groups. The experimental group will receive standard care plus a multidomain intervention including supervised and home-based exercise training, individualized nutritional counseling, and oral protein and iron supplementation. The control group will receive standard care alone. Because of the nature of the intervention, participants and treating investigators will not be blinded to group assignment. Clinical outcomes will be adjudicated by an independent committee blinded to treatment allocation. Randomization will be centralized and stratified by participating center, sex, baseline physical performance, and baseline nutritional status.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Campo, University Hospital of Ferrara
- Investigators
- Elisabetta Tonet, MD, Principal investigator, University Hospital of FerraraGianluca CAMPO, MD, Study chair, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895719
- Sponsor's protocol ID
- 341/2026/Sper/AOUFe
- Other IDs
- GR-2024-12377447
- Acronym
- IRON-TAVI
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
- ClinicalTrials.gov ID
- NCT07895719
- Acronym / sponsor ID
- IRON-TAVI / 341/2026/Sper/AOUFe
- Keywords
- aortic stenosis, prehabilitation, cardiac rehabilitation, transcatheter aortic valve implantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 4 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Nov 2031 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a one-to-one ratio to two parallel groups. The experimental group will receive standard care plus a multidomain intervention including supervised and home-based exercise training, individualized nutritional counseling, and oral protein and iron supplementation. The control group will receive standard care alone. Because of the nature of the intervention, participants and treating investigators will not be blinded to group assignment. Clinical outcomes will be adjudicated by an independent committee blinded to treatment allocation. Randomization will be centralized and stratified by participating center, sex, baseline physical performance, and baseline nutritional status.
| Arm | Type | Receives |
|---|---|---|
| Multidomain intervention | Experimental | Behavioral: Personalized Multidomain Exercise Program, Dietary Supplement: Oral Protein and Iron Nutritional SupplementationParticipants 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. |
| Standard of care | Other | Other: Usual CareParticipants 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Multidomain Exercise ProgramParticipants 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. | Behavioural | Multidomain intervention |
| Oral Protein and Iron Nutritional SupplementationParticipants 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. | Dietary supplement | Multidomain intervention |
| Usual CareParticipants 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. | Other | Standard of care |
Primary outcome
Time to First All-Cause Death, Stroke, or Hospital Readmission for Cardiovascular Causes
Time frame: From randomization through 12 months
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.
7 secondary outcomes
All-cause death
Time frame: From randomization through 12 months
Cardiovascular death
Time frame: From randomization through 12 months
Stroke
Time frame: From randomization through 12 months
Myocardial infarction
Time frame: From randomization through 12 months
Hospital readmission for heart failure
Time frame: From randomization through 12 months
Hospital readmission for cardiovascular cause
Time frame: From randomization through 12 months
Hospital readmission for any cause
Time frame: From randomization through 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elisabetta Tonet, MD principal investigator
University Hospital of Ferrara
Gianluca CAMPO, MD study chair
University Hospital of Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Multidomain Exercise Program and Oral Protein and Iron Nutritional Supplementation in people with Aortic Stenosis Disease and Aortic Stenosis Symptomatic, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veronica Lodolini (0532236450 ext. +39, ldlvnc@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First All-Cause Death, Stroke, or Hospital Readmission for Cardiovascular Causes (time frame: From randomization through 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.