HART-CT
Research type
Research Study
Full title
In patients taking Protease Inhibitors does switching to a Bictegravir, Tenofovir Alafenamide and Emtricitabine combination, reduce cardiovascular risk: An open-label, randomised, serial CT pilot study
IRAS ID
238674
Contact name
Thomas Heseltine
Contact email
Sponsor organisation
University of Liverpool
Eudract number
2017-005033-22
Duration of Study in the UK
2 years, 0 months, 5 days
Research summary
Combined antiretroviral therapy (cART) is thought to promote atherosclerosis via a number of mechanisms: Dyslipidaemia, endothelial dysfunction, hypertension, insulin resistance and renal impairment are the main pathological mechanisms driving atherosclerosis as a consequence of cART. An association between Protease Inhibitors and increased cardiovascular disease has been shown in many large cohort trials.
CT Coronary Angiography (CTCA) is now widely used to assess for the presence of atherosclerosis, typically in patients presenting with chest pain. We are now able to perform high quality diagnostic scans with radiation exposure as low as 1-2mSv thanks to dual source technology and increased gantry spin rates.
We have designed an open label, prospective, randomised-control pilot study to investigate the feasibility of performing a future appropriately powered multi-centred randomised control trial. Primary outcome data will be generated to assess rate of recruitment and drop out rate.
The design of our pilot study also concentrates on assessment of any changes in coronary plaque on serial CTCA (as a surrogate marker of cardiac risk attributed to swapping from PI to Bictegravir based therapy). We will calculate standard deviations from plaque outcomes measures to enable calculation of the sample size required to power a large multi-centre randomised-control trial. If a patient has no evidence of coronary plaque on an initial CTCA they will not undergo a second CTCA study.
Important secondary outcome measures will include changes in metabolic profile, changes in coronary plaque profiles, assessment of the incidence of subclinical CVD in our local population. We will also assess the performance of traditional CVD risk assessment tools (JBS3, QRISK 3 and Frammingham) against CT based risk prediction models.
We will assess the appropriateness of the study design from a patient perspective and the rate of recruitment to gain insight into the length of time required to run the future investigation.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
18/YH/0431
Date of REC Opinion
31 Jan 2019
REC opinion
Further Information Favourable Opinion