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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Veronica Lodolini
- Puhelinnumero: +39 0532236450
- Sähköposti: ldlvnc@unife.it
Opiskelupaikat
-
-
FE
-
Ferrara, FE, Italia
- Rekrytointi
- Azienda Ospedaliero Universitaria di Ferrara
-
Ottaa yhteyttä:
- Elisabetta Tonet
- Puhelinnumero: +39 0532237227
- Sähköposti: tonet.elisabetta@gmail.com
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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. |
|
Muut: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Time to First All-Cause Death, Stroke, or Hospital Readmission for Cardiovascular Causes
Aikaikkuna: 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. |
From randomization through 12 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
All-cause death
Aikaikkuna: From randomization through 12 months
|
Clinical outcome defined as the time from randomization to the first occurrence of all-cause death. |
From randomization through 12 months
|
|
Cardiovascular death
Aikaikkuna: From randomization through 12 months
|
Clinical outcome defined as the time from randomization to the first occurrence of cardiovascular death. |
From randomization through 12 months
|
|
Stroke
Aikaikkuna: From randomization through 12 months
|
Clinical outcome defined as the time from randomization to the first occurrence of stroke. |
From randomization through 12 months
|
|
Myocardial infarction
Aikaikkuna: From randomization through 12 months
|
Clinical outcome defined as the time from randomization to the first occurrence of myocardial infarction. |
From randomization through 12 months
|
|
Hospital readmission for heart failure
Aikaikkuna: From randomization through 12 months
|
Clinical outcome defined as the time from randomization to the first occurrence of hospital readmission for heart failure |
From randomization through 12 months
|
|
Hospital readmission for cardiovascular cause
Aikaikkuna: From randomization through 12 months
|
Clinical outcome defined as the time from randomization to the first occurrence of hospital readmission for cardiovascular cause |
From randomization through 12 months
|
|
Hospital readmission for any cause
Aikaikkuna: From randomization through 12 months
|
Clinical outcome defined as the time from randomization to the first occurrence of hospital readmission for any cause |
From randomization through 12 months
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Primary safety endpoint
Aikaikkuna: From randomization through 12 months
|
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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Elisabetta Tonet, MD, University Hospital of Ferrara
- Opintojen puheenjohtaja: Gianluca CAMPO, MD, University Hospital of Ferrara
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 341/2026/Sper/AOUFe
- GR-2024-12377447 (Muu apuraha/rahoitusnumero: Italian Health Minister - Ricerca Finalizzata 2024)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .