Predicting outcomes following intervention for tricuspid regurgitation

ISRCTN	ISRCTN28956316
DOI	https://doi.org/10.1186/ISRCTN28956316
IRAS number	340256
Secondary identifying numbers	CPMS 61262

Submission date: 10/02/2025
Registration date: 03/04/2025
Last edited: 20/05/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
This study focuses on a heart condition called tricuspid valve regurgitation (TR), where blood flows backward across the heart's tricuspid valve. This is a common issue, especially in patients who are at high risk for surgery and have had no treatment options until now. Severe TR is linked to higher death rates. Recently, new keyhole treatments have been developed that can fix the heart valve without surgery. These treatments include tricuspid transcatheter edge-to-edge repair (T-TEER) and tricuspid valve replacement (TTVR), collectively known as transcatheter tricuspid valve intervention (TTVI). The study aims to understand how patients respond to these treatments and to identify which patients might benefit the most.

Who can participate?
Patients with severe or greater tricuspid regurgitation who are considered suitable for transcatheter tricuspid valve intervention after a discussion with a multidisciplinary team can participate in this study.

What does the study involve?
Participants will undergo transcatheter tricuspid valve interventions for severe tricuspid regurgitation. They will have additional functional and quality-of-life assessments at the start of the study and during follow-up visits. The study will also involve invasive physiology assessments before and after treatment to understand how the treatment affects heart function. Researchers will look at the relationship between changes in heart function and changes in quality of life and physical ability.

What are the possible benefits and risks of participating?
The possible benefits include receiving a new treatment that could improve heart function and quality of life. However, there are risks, such as the potential for the heart to worsen suddenly if the leak is completely fixed, causing pressure overload. The study aims to identify markers that predict how well patients will respond to treatment.

Where is the study run from?
King's College London (UK)

When is the study starting and how long is it expected to run for?
December 2024 to March 2028.

Who is funding the study?
Edwards Lifesciences (USA)

Who is the main contact?
Dr Benedict McDonaugh, benedict.mcdonaugh@gstt.nhs.uk

Contact information

Dr Benedict McDonaugh
Public, Scientific, Principal Investigator

St Thomas' Hospital, Westminster Bridge Road
London
SE1 7EH
United Kingdom

ORCID ID	0009-0000-0613-7647
Phone	+44 20 7188 7188
Email	benedict.mcdonaugh@gstt.nhs.uk

Study information

Study design	Multicentre observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Quality of life, Treatment, Efficacy
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	Predicting functional and clinical outcomes following transcatheter tricuspid valve intervention for severe tricuspid regurgitation
Study acronym	PREDICT-TR
Study hypothesis	1. Baseline invasively measured contractility and ventricle-arterial coupling will predict functional response to Transcatheter Tricuspid valve intervention. 2. Atrial secondary tricuspid regurgitation (A-STR) will show an improvement in cardiac output over Ventricular secondary (V-STR) post-TTVI.
Ethics approval(s)	Submitted 16/12/2024, West London Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8098; westlondon.rec@hra.nhs.uk), ref: Reference number not provided
Condition	Tricuspid regurgitation, heart failure
Intervention	We will observe patients undergoing Transcatheter Tricuspid valve interventions for severe tricuspid regurgitation. We will perform some additional functional and quality-of-life assessment at baseline and at follow-up to try and understand which patients yield the greatest benefit from treatment. We will perform invasive physiology assessment before and after treatment to understand how the treatment affects cardiovascular physiology. We will assess the correlation between changes in invasive physiology and changes in quality-of-life and functional capacity. The overall aim of the study is to assess which baseline clinical, imaging and physiology characteristics correlate with treatment response to refine patient selection for tricuspid interventions.
Intervention type	Other
Primary outcome measure	1. Cardiac output measured invasively immediately before and after tricuspid intervention procedure. 2. Cardiac output measured non-invasively at baseline, the day of and <48hrs after tricuspid intervention procedure, at 12 weeks follow-up
Secondary outcome measures	1. Change in cardiac contractility measured invasively: measured immediately before and after tricuspid intervention procedure. 2. Change in cardiac function (ejection fraction and cardiac output) measured with non-invasive cardiac imaging: measured at baseline, the day of and <48hrs after tricuspid intervention procedure, at 12 weeks follow-up 3. Change in symptoms measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ): measured at baseline and at 12 weeks follow-up 4. Change in exercise capacity measured with 6-minute walk test (6MWT) and average daily step count measured with wearable activity monitors: measured at baseline and at 12 weeks follow-up
Overall study start date	16/12/2024
Overall study end date	01/03/2028

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	72
Participant inclusion criteria	Patients with severe or greater tricuspid regurgitation and deemed suitable for Transcatheter tricuspid valve intervention after multidisciplinary team discussion.
Participant exclusion criteria	1. Anatomical or haemodynamic exclusion for TTVI 2. Pregnancy 3. Age <18 years 4. Congenital heart disease requiring intervention/surgery 5. Significant (>moderate in severity) non-tricuspid valvular disease 6. Another indication for cardiac surgery 7. Enrolment in other studies that may lead to deviation from either protocol
Recruitment start date	01/03/2025
Recruitment end date	01/03/2028

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Guy's and St Thomas' Hospitals

Trust Offices
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Royal Brompton Hospital

Sydney Street
London
SW3 6NP
United Kingdom

John Radcliffe Hospital

Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Sponsor information

King's College London
University/education

St Thomas' Hospital
Westminster Bridge Road
London
SE1 9RT
England
United Kingdom

Phone	+44 20 7188 7188
Email	rgo@kcl.ac.uk
Website	http://www.kcl.ac.uk/index.aspx
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Industry

Edwards Lifesciences
Government organisation / For-profit companies (industry)

Alternative name(s): Edwards, Edwards Lifesciences Corporation, Edwards Lifesciences Corp., Edwards Lifesciences LLC, ELC
Location: United States of America

Results and Publications

Intention to publish date	01/03/2029
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Data will be published in peer-reviewed journals and via conference presentations. Lay summary of results will be made available via study website.
IPD sharing plan	The datasets generated and analysed during the current study will be available upon written request from the research team - contactable via Dr Tiffany Patterson, Consultant Cardiologist, St Thomas' Hospital, Westminster Bridge Road, London, SE1 9RT.

Editorial Notes

20/05/2025: Internal review.
31/03/2025: Trial's existence confirmed by NHS HRA.