Clinical trial NCT06121921: RESTORE-TAVI Pilot
Official title: A Pilot Study Assessing the Feasibility and Effectiveness of a Perioperative Multi-component Intervention in Patients With Acute Decompensated Aortic Stenosis Undergoing Urgent Transcatheter Aortic Valve Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Aortic Stenosis
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: Imperial College London
First posted: 2023-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

1. Age \> 70 years
2. Ability to provide written informed consent
3. Ability to speak English

Exclusion criteria:

1. Clinical instability defined as requiring use of inotropes/mechanical-circulatory support during admission or post-cardiac arrest
2. Active delirium (4AT score ≥ 4) at time of recruitment
3. Parkinson's disease (Hoehn \& Yahr stage 3-5)
4. Recent stroke (within 7 days preceding recruitment)
5. Terminal condition (e.g. metastatic cancer) with life expectancy \< 12 months
6. Clinical unsuitable for recruitment to trial according to the discretion of the research team

Primary outcomes:
measure: Feasibility: Recruitment rates
timeFrame: 1 year
measure: Feasibility: Safety
timeFrame: On discharge: e.g. 2-7 days
Secondary outcomes:
measure: Incidence of hospital-acquired disability
timeFrame: 30 days
measure: Incidence of delirium
timeFrame: Daily (during inpatient admission) until the seventh day post-TAVI and then twice weekly thereafter
measure: Changes in health-related quality of life
timeFrame: 30 days
measure: Changes in physical frailty
timeFrame: 30 days
measure: Changes in physical frailty
timeFrame: On discharge: e.g. 2-7 days
measure: Changes in physical frailty
timeFrame: On discharge: e.g. 2-7 days
measure: Change in cognitive function
timeFrame: 30 days
measure: Change in mood
timeFrame: 30 days
measure: Incidence of falls during hospitalisation
timeFrame: On discharge: e.g. 2-7 days
measure: Length of hospital stay
timeFrame: On discharge: e.g. 2-7 days
measure: Discharge destination
timeFrame: On discharge: e.g. 2-7 days
measure: Unplanned readmissions
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts and the London NHS Trust
Study officials:
References: