Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial (IRON-TAVI)
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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Veronica Lodolini
- Telefoonnummer: +39 0532236450
- E-mail: ldlvnc@unife.it
Studie Locaties
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FE
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Ferrara, FE, Italië
- Werving
- Azienda Ospedaliero Universitaria di Ferrara
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Contact:
- Elisabetta Tonet
- Telefoonnummer: +39 0532237227
- E-mail: tonet.elisabetta@gmail.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Multidomain intervention
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. |
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. |
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Ander: Standard of care
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. |
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Time to First All-Cause Death, Stroke, or Hospital Readmission for Cardiovascular Causes
Tijdsspanne: From randomization through 12 months
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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. |
From randomization through 12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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All-cause death
Tijdsspanne: From randomization through 12 months
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Clinical outcome defined as the time from randomization to the first occurrence of all-cause death. |
From randomization through 12 months
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Cardiovascular death
Tijdsspanne: From randomization through 12 months
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Clinical outcome defined as the time from randomization to the first occurrence of cardiovascular death. |
From randomization through 12 months
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Stroke
Tijdsspanne: From randomization through 12 months
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Clinical outcome defined as the time from randomization to the first occurrence of stroke. |
From randomization through 12 months
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Myocardial infarction
Tijdsspanne: From randomization through 12 months
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Clinical outcome defined as the time from randomization to the first occurrence of myocardial infarction. |
From randomization through 12 months
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Hospital readmission for heart failure
Tijdsspanne: From randomization through 12 months
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Clinical outcome defined as the time from randomization to the first occurrence of hospital readmission for heart failure |
From randomization through 12 months
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Hospital readmission for cardiovascular cause
Tijdsspanne: From randomization through 12 months
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Clinical outcome defined as the time from randomization to the first occurrence of hospital readmission for cardiovascular cause |
From randomization through 12 months
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Hospital readmission for any cause
Tijdsspanne: From randomization through 12 months
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Clinical outcome defined as the time from randomization to the first occurrence of hospital readmission for any cause |
From randomization through 12 months
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Primary safety endpoint
Tijdsspanne: From randomization through 12 months
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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. |
From randomization through 12 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Elisabetta Tonet, MD, University Hospital of Ferrara
- Studie stoel: Gianluca CAMPO, MD, University Hospital of Ferrara
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 341/2026/Sper/AOUFe
- GR-2024-12377447 (Ander subsidie-/financieringsnummer: Italian Health Minister - Ricerca Finalizzata 2024)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
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