Clinical Activities

The Barts Cardiovascular Clinical Trials Unit (CV CTU)

The Barts Cardiovascular Clinical Trials Unit is in the process of being set up. The Unit will be NIHR compliant and will support the development of research within the Barts Heart Centre. It will provide trials expertise internal to Barts and will support all areas of the cardiovascular research programme and will form part of the Barts CTU (a UKCRC registered unit). 

What type of studies does the CV CTU support?

It supports Clinical Trials of Investigational Medicinal Products (CTIMPs), non-CTIMPs (which include trials of complex interventions) and device studies, whether these are single centre, multi-centre, national or international studies. The aim is to support local investigators to deliver high-quality trials by providing oversight of the main trial activities. The CV CTU is a core resource providing infrastructure support for clinical cardiovascular research within Barts and QMUL.

What constitutes CTU involvement?

If you wish to have the CTU as your official CTU for the study it will oversee the main trial activities including: design, risk assessment, costings, protocol development, obtaining approvals (MHRA, NRES, NHS), regulatory and ethics submissions, statistical design and analysis, study oversight, data management, database development, randomisation and unblinding, patient and public involvement, IMP management and recruitment of study staff. 

Is my project a CTIMP?

Check the MHRA algorithm

What should I do if I would like support from the CV CTU?

Download and complete the CV CTU enquiry form and submit to Vivienne Monk at 

What is the process for CV CTU interim approval?

This flowchart explains the current process for interim approval of projects and how this works with the Barts Heart Centre Peer Review Process.

Key contacts

For general enquiries please contact Vivienne Monk at or

Barts Trust logo     Barts Heart Centre logo


The new Barts Cardiovascular Clinical Trials Unit (CV CTU) will be NIHR compliant and will support the development of research within the Barts Heart Centre. It will provide trials expertise internal to Barts and enable us to grow our NIHR and BHF funded clinical research funding. The CTU will support all areas of the CV research programme and allow us to increase our funding across the speciality area. 

  • Will be a part (branch – there are already 4) of the Barts CTU (a UKCRC registered unit)
  • Will bring together the expertise needed to undertake a clinical trial from the William Harvey Clinical Research Centre (21 staff), the Barts Heart Centre (16 staff) and the CV BRU, along with funding for 5 new posts
  • This will create an NIHR compliant CV CTU

Will provide expertise and advice in the following areas:

  • Trial design, sample size and statistics
  • Developing proposals and funding applications
  • Project management
  • Regulations and governance
  • Patient and Public Involvement
  • Quality management
  • Database development
  • Recruitment of patients (and staff)
  • Trial oversight and day to day management 

The set up of the CV CTU is being overseen by a Working Group constituted as follows:

Interim Chair: Professor Amrita Ahluwalia, WHRI
Project Manager: Dr Vivienne Monk, WHRI Clinical Research Centre Manager


Professor Mark Caulfield, WHRI
Dr Sam Mohiddin, Consultant Cardiologist Barts Heart Centre and Chair of Peer Review Committee
Professor Steffen Petersen, Director of Research Barts Heart Centre
Dr David Collier, Joint Clinical Director WHRI Clinical Research Centre
Benoit Aigret, Head of Barts CTU
Chris Smith, Programme Manager QMUL

Any general enquiries should be made to Vivienne Monk

William Harvey Clinical Research Centre

The Clinical Research Centre (CRC) was established in 1997 and moved to the newly built William Harvey Heart Centre (part of the William Harvey Research Institute, Barts and The London School of Medicine and Dentistry) in 2011. The Centre is part of the National Institute for Health Research Barts Biomedical Research Centre and part of the world leading cardiovascular research programme at the new Barts Heart Centre, which is now the largest tertiary heart hospital in the UK. 

Initially, the centre focused on blood pressure and cholesterol studies (such as ASCOT, Pathway and ILLUMINATE). The centre has widened its portfolio to include diabetes/renal, endocrine, respiratory and cognitive decline studies. The centre runs all types of studies ranging from niche complex studies on rare diseases to large scale trials and health service interventions.

The CRC runs clinical trials (Phase II to IV) in multiple therapeutic areas. As well as clinical trials of investigational medicinal products (CTIMPs) the centre also runs device trials and other observational studies. We have a broad portfolio of studies and involve Principal Investigators from Barts Health Trust as well as from Queen Mary University of London (QMUL).

We are involved in a number of patient and public engagement activities and actively work with GP practices serving 500,000 people in East London. 


Our vision is to be a world-class clinical research centre conducting globally influential trials that make a positive impact on patient care locally. We aim to: 

  • Build on our international, reputation in translational and clinical research
  • Play a key role in the cardiovascular research programme at the new Barts Heart Centre
  • Offer patients a large portfolio of clinical trials that they can participate in
  • Promote the public understanding of clinical trials.


Our values are central to how we work to achieve our aims. We work in a way that is:

  • Focused on safety and quality of patient care
  • Conducive to building ongoing relationships with local GP practices and Principal Investigators within Barts Trust
  • In line with Good Clinical Practice and provision of a quality service.


Our strategic goals are to: 

  1. Increase patient participation in clinical trials
  2. Diversify our portfolio of studies
  3. Ensure the conduct of our trials is to the highest quality standards
  4. Deliver our studies to time and target.

Links to Barts Health Trust and Quintiles

The Centre is situated in central London on the QMUL campus of the Barts School of Medicine and we have strong links with Barts Health Trust. The Barts Health Trust is the largest in the UK and the new Barts Heart Centre is the largest tertiary heart hospital in the UK. Cardiovascular research will expand with the coming together of the research groups from the London Chest Hospital and the UCL Heart Hospital. 

The University College London Partners (UCLP) Quintiles Prime Site based here, has now expanded across UCLP. It is the world’s largest Prime Site. The Prime Site concentrates clinical trials across multiple therapeutic areas in a single hub and last year was one of the top recruiters worldwide. London is the most active research area within England and we have access to a large and ethnically diverse patient population in inner London. 


  • The first UK renal denervations were done here in 2008 and the first twin-artery denervations in the world. These studies have resulted in two Lancet publications
  • ASCOT, now with a long-term follow-up study ASCOT-10, has been one of the most influential trials in cardiovascular prevention, with over 100 papers and atorvastatin has become the biggest selling medication in the world
  • Hi-Lo with over 9,000 patients has been the highest accruing study on the NIHR portfolio for several years. After the Hi-Lo intervention Tower Hamlets went from worst to best for control of blood pressure and cholesterol control
  • The CRC is often one of the highest recruiters globally on the studies on our portfolio.

Where are we? Current status

Currently, the Centre has circa forty clinical trials with about thirty open to recruitment.

Approximate breakdown of trials by type:

  • Cardiovascular (55%), diabetes and endocrinology (10%), respiratory (25%), mental health and neurology (10%).

Patient Studies

Studies currently recruiting:

High blood pressure study - volunteers needed

  • Do you have High Blood Pressure? We need your help to be a volunteer.
  • Do you have high blood pressure and taking a single blood pressure medication?
  • Aged between 40 - 75 years and in good general health?

We can reimburse for travel and inconvenience

If you are eligible to take part in our ethically approved trials, you will be helping in the research for new medicines.

Download flyer for more info. 

TIME study

The big question is, would taking blood pressure medication in the evening be better (or worse) than taking it in the morning in preventing strokes and heart attacks? The TIME study will try to answer this question

SPIRE study

We are currently recruiting patients with high cholesterol and a history of heart disease, kidney disease or diabetes for a study of an investigational medication. Find out more about the SPIRE Study.

The Strength Trial – Help us to find a way to protect your heart

Do you take statins? Do you have a history of heart attack or stroke? Are you at high risk of heart attack or stroke?

We are currently recruiting patients for a clinical research study looking at a concentrate of omega-3 fatty acids to see whether it can help to decrease the risk of serious heart problems in people diagnosed as having a high risk of heart disease.

Watch our videos to learn more about what's involved and how you can participate. 

WAVE iV study

Join our trial of “life changing” one-hour treatment to lower blood pressure. Local people suffering from uncontrolled high blood pressure are being invited to take up an exciting new treatment using ultrasound-based energy, being trialled for the first time in London at St Bartholomew’s Hospital this summer.

The one-hour treatment is an exciting and innovative opportunity for the estimated 4% [1] of adults in London living with resistant hypertension - a severe form of high blood pressure that cannot be controlled with drug therapy, putting them at constant risk of suffering a stroke or severe heart problems.

The treatment is the subject of a randomised clinical trial known as WAVE IV. In previous trials of the therapy, three-quarters of treated patients experienced a meaningful reduction in their blood pressure following the one-time, one-hour therapy.

Now, people in east London are being given the chance to sign up to the randomised trial being run by Queen Mary University of London and Barts Health NHS Trust.

Patients may be eligible to participate in the WAVE IV clinical study if:

•    They are aged between 18 years of age and 90 years of age.
•    Their systolic blood pressure (top number) is greater than 160 mmHg.
•    They are currently taking three or more prescription medications for high blood pressure.

People who wish to find out more and assess their suitability for the trial can contact Anne Zak at the William Harvey Heart Centre Clinical Trials Unit on 0207 882 5657.


The CARMELINA Study is a Phase 4 clinical trial. The purpose of the CARMELINA Study is to look at the impact of linagliptin on the long-term occurrence of selected complications of cardiovascular disease (e.g. stroke or heart attack), as compared to placebo, in people with type 2 diabetes mellitus receiving standard of care. Find out more about the CARMELINA study.

Credence study

The Credence study is looking at an investigational medication versus placebo to see if it can slow down the progression of kidney disease in patients with Type 2 Diabetes. Find out more about the CREDENCE study.

Odyssey study

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome. Find out more about the Odyssey study.

Optimize study

We are currently recruiting patients for a clinical research study looking at an investigational medication for people with severe COPD that is already approved at a particular dose in more than 60 countries. This study looks at how effective the investigational medication is when it is taken at different doses. The study medication is a tablet taken once a day in addition to your existing COPD treatments. For further details click. Find out more about the Optimize study.

Tommorrow study (CLOSED)

The Tommorrow study is researching a new investigational test to see if it can help identify individuals who are at higher risk of developing memory problems due to Alzheimer’s disease in the next 5 years, and testing a new investigational treatment to see if it can delay the memory problems due to Alzheimer’s disease. This research study is currently recruiting healthy older participants. Find out more about being part of this new research effort. Find out more about the Tommorrow study.

Fourier study (CLOSED)

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease. Find out more about the Fourier study.