Precision Medicine With Zibotentan in Microvascular Angina
Status:
Recruiting
Trial end date:
2022-11-30
Target enrollment:
Participant gender:
Summary
Microvascular angina (MVA) is caused by abnormalities of the small vessels in the heart.
Endothelin is a small chemical that circulates and accumulates in the blood vessel walls,
causing them to narrow or go into spasm and thicken in the longer term especially as levels
of endothelin increase. As a result, patients experience pain, psychological burden and an
inability to carry out daily activities.
Originally developed by AstraZeneca for cancer treatment, prior research has confirmed that
Zibotentan relaxes the small blood vessels of patients with MVA which lends support to the
idea that Zibotentan may bring some benefits to patients with MVA. This trial therefore
proposes to look into re-purposing zibotentan as a new treatment for patients with MVA. The
primary objective is to assess the effect of add-on treatment with Zibotentan to treadmill
exercise times in adult patients with MVA and impaired exercise intolerance. Zibotentan could
provide a new treatment pathway for patients, as well as be made available to the NHS at
substantially lower cost than the currently used medications.
The trial aims to initially invite approx. 356 participants for genetic testing. A minimum of
100 participants will go forward into the main study, receiving either 10mg zibotentan or a
dummy matched tablet (placebo) daily over two 12 weeks periods of each, completing their
final visit at week 34. The study assessments will involve a health check at each visit,
including information on the patient's wellbeing, blood tests, some quality of life
questionnaires, and an exercise test. Participants will also have the option to consent to
additional sub-study cardiovascular MRI scanning. Finally, participants will be invited to
provide consent for long-term follow-up (maximum 20 years) of their electronic medical
records (no additional patient contact).
Phase:
Phase 2
Details
Lead Sponsor:
NHS Greater Glasgow and Clyde
Collaborators:
AstraZeneca UK Ltd Blackpool Teaching Hospitals NHS Foundation Trust King's College London Oxford University Hospital NHS Foundation Trust Papworth Hospital NHS Foundation Trust Royal Free London NHS Foundation Trust Siemens Healthcare Ltd The University of Cambridge The University of Glasgow The University of Oxford University of Glasgow