Status:
COMPLETED
Precision Medicine With Zibotentan in Microvascular Angina
Lead Sponsor:
NHS Greater Glasgow and Clyde
Collaborating Sponsors:
University of Glasgow
King's College London
Conditions:
Microvascular Angina
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 narro...
Detailed Description
The study design publication is available at https://pubmed.ncbi.nlm.nih.gov/32942043/
Eligibility Criteria
Inclusion
- Age \>18 years.
- Microvascular angina - as defined by COVADIS diagnostic criteria for microvascular angina.
- Able to comply with study procedures.
- Written informed consent.
Exclusion
- Exercise tolerance \>540 seconds in men and \>430 seconds in women (i.e. actual exercise duration (s) achieved on the Bruce protocol commensurate with predicted), or, lack of anginal symptoms and/or ST-segment depression (0.1 mV) limiting exercise.
- Non-cardiovascular exercise-limiting problem e.g. morbid (or severe) obesity (BMI ≥40.0 kg/m2)
- Genotype not available
- Women who are pregnant, breast-feeding or of child-bearing potential (WoCBP) without a negative pregnancy test and who are unwilling or unable to follow the reproductive restrictions and use highly effective contraception as defined in Appendix 3 of the protocol for the duration of the study treatment and 30 days after last dose of study drug.
- Men who are sexually active with a WoCBP who are unwilling to use condoms or other highly effective methods of contraception for the duration of study treatment and for 14 weeks after last dose of study drug.
- Heart failure (New York Heart Association Grade ≥II i.e. mild symptoms and slight limitation during ordinary activity)
- Recent (\<3 months) myocardial infarction
- A history of epilepsy, other CNS adverse events, neurologic symptoms or signs consistent with spinal cord compression or CNS metastases.
- Moderate or more severe renal impairment (GFR \< 45 mL/min)
- Liver disease with a Child-Pugh score of A (5-6 points) or higher
- Participation in another intervention study involving a drug within the past 90 days or 5 half-lives whichever is longer (co-enrolment in observational studies is permitted).
Key Trial Info
Start Date :
October 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2023
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT04097314
Start Date
October 18 2019
End Date
June 8 2023
Last Update
August 4 2023
Active Locations (1)
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1
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom