RESTORE-TAVI Pilot
- Conditions
- FrailtyAortic Stenosis
- Interventions
- Other: Perioperative multi-component intervention
- Registration Number
- NCT06121921
- Lead Sponsor
- Barts & The London NHS Trust
- Brief Summary
This is a pilot randomised control study assessing the feasibility and effectiveness of a perioperative multi-component intervention aimed at reducing adverse hospital events and improving functional outcomes in patients with acute decompensated aortic stenosis undergoing urgent transcatheter aortic valve implantation compared to standard care.
The intervention will consist of physical rehabilitation, delirium prevention, nutritional supplementation and anaemia correction (where indicated). The primary objective is to determine the feasibility and safety of delivering this intervention Secondary objectives include investigating the impact on adverse hospital events such as hospital-acquired disability and post-TAVI delirium, and on health-related quality of life and functional recovery following TAVI.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 52
- Age > 70 years
- Ability to provide written informed consent
- Ability to speak English
Exclusion criteria:
- Clinical instability defined as requiring use of inotropes/mechanical-circulatory support during admission or post-cardiac arrest
- Active delirium (4AT score ≥ 4) at time of recruitment
- Parkinson's disease (Hoehn & Yahr stage 3-5)
- Recent stroke (within 7 days preceding recruitment)
- Terminal condition (e.g. metastatic cancer) with life expectancy < 12 months
- Clinical unsuitable for recruitment to trial according to the discretion of the research team
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Perioperative multi-component intervention Perioperative multi-component intervention
- Primary Outcome Measures
Name Time Method Feasibility: Safety On discharge: e.g. 2-7 days In-hospital adverse events (e.g. falls, ischaemia, arrhythmia, acute kidney injury), in-hospital mortality
Feasibility: Recruitment rates 1 year Average number of patients per month willing to give informed consent and be randomised into a trial of a perioperative frailty intervention
- Secondary Outcome Measures
Name Time Method Change in cognitive function 30 days Assessed using T-MoCA at admission and 30 days post discharge via telephone
Incidence of hospital-acquired disability 30 days defined as loss of ≥ 1 ADL at discharge compared to admission; and followed-up at 30 days after discharge
Incidence of delirium Daily (during inpatient admission) until the seventh day post-TAVI and then twice weekly thereafter Assessed daily during hospitalisation by using 4AT until the seventh day post-TAVI and then twice weekly thereafter
Changes in health-related quality of life 30 days Measured using EQ-5D-5L at baseline and 30 days post discharge via telephone
Changes in physical frailty On discharge: e.g. 2-7 days By comparing timed chair rises at admission and discharge - time (measures in seconds) to complete five chair rises without using arms.
Change in mood 30 days Assessed using HADS at admission and 30 days post discharge via telephone
Incidence of falls during hospitalisation On discharge: e.g. 2-7 days Length of hospital stay On discharge: e.g. 2-7 days Duration of inpatient stay at tertiary centre
Discharge destination On discharge: e.g. 2-7 days e.g. to patient's own home, long-term care facility or district general hospital
Unplanned readmissions 30 days Measured at 30 days post discharge from tertiary centre using hospital records and patient telephone-interview
Mortality 30 days Measured at 30 days post discharge using hospital records and NHS Spine database