TRUST

• Research type

  Research Study

• Full title

  TRicuspid Uk STudy

• IRAS ID

  338776

• Contact name

  Michael Mullen

• Contact email

  mmullen@nhs.net

• Sponsor organisation

  Barts Health NHS Trust

• Clinicaltrials.gov Identifier

  NCT07133386

• Duration of Study in the UK

  2 years, 11 months, 31 days

• Research summary

  Tricuspid regurgitation (TR) is a common heart valve condition that can cause severe symptoms, reduce quality of life (QoL), and shorten life expectancy. Many people with TR are elderly and have other health problems. For them, feeling better and improving daily life can be just as important or more important than living longer. Currently, treatment options are limited. Medications (such as water tablets) can provide some relief but often have side effects and may not work well. Surgery is an option but is rarely done because it carries high risks and often leads to poor results. As a result, TR is often left untreated.
  A newer, less invasive procedure called TriClip uses a small device to clip parts of the tricuspid valve together, reducing leakage. Previous studies showed that TriClip improved patients’ quality of life compared to medication, but it didn’t help them live longer or reduce hospital visits. However, because quality of life is subjective, the improvements could have been influenced by the placebo effect.

  This study will investigate whether TriClip truly improves quality of life and symptoms in people with severe or more TR.

  The TRicuspid Uk STudy (TRUST) is a randomised, blinded, placebo-controlled trial (meaning some patients will receive the real procedure while others will receive a placebo, and neither the patients nor the researchers will know who got what). It will take place across multiple hospitals and include 150 patients with severe TR. The main goal is to measure changes in quality of life using a questionnaire (Kansas City Cardiomyopathy Questionnaire) up to 3 months after the procedure. Other factors like symptoms, walking ability, hospital visits, and safety will also be assessed. The trial will run for 3 years.

  The results will be shared at international conferences and published in a major medical journal. The findings are expected to change clinical practice within 5 years, leading to better treatment options and improved quality of life for people with TR.
  

• REC name

  South East Scotland REC 02

• REC reference

  25/SS/0099

• Date of REC Opinion

  21 Jan 2026

• REC opinion

  Further Information Unfavourable Opinion