THE MOLTEN STUDY
Research type
Research Study
Full title
DEVELOPMENT OF A CT RADIOMICS APPROACH TO ASSESS PERIVASCULAR FAT MODIFICATION AND TO PREDICT BLOOD PRESSURE RESPONSE AFTER RENAL ARTERY DENERVATION: THE MOLTEN STUDY
IRAS ID
335877
Contact name
Giovanni Luigi De Maria
Contact email
Sponsor organisation
Research and Development Department Joint Research Office Oxford University Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Hypertension or high blood pressure is the leading risk factor for cardiovascular death globally. Renal denervation therapy is a CE mark, NICE and FDA approved treatment for the management of hypertension. It works by delivering radiofrequency energy from inside the renal arteries to the fat surrounding the nerves to the kidney. This causes thermal injury to the fat and interrupts the nerve signals to the kidneys, which lowers blood pressure.
This treatment has been shown in large trials to lower blood pressure. However, approximately 30% of patients do not benefit from the procedure with little or no blood pressure reduction. Currently, we cannot tell if the denervation therapy has been delivered effectively to the nerves or which patients are likely to respond to renal denervation therapy. Therefore, we propose the MOLTEN study, aiming to identify radiological markers on CT to detect changes in the fat around the nerves shortly after renal denervation therapy and after a recovery period. These radiological markers may indicate whether or not an effective treatment has been delivered. Subsequently, machine learning algorithms can be trained to identify pre-procedural and post-procedural radiomic markers that can be associated with long term reduction in blood pressure.
In summary the MOLTEN study aims to:
1) identify CT radiomic markers of acute thermal injury and re-modelling post-renal denervation (PRIMARY AIM)
2) generate a preliminary model linking radiomic markers pre and post renal denervation to blood pressure response (SECONDARY EXPLORATORY AIM)To do this we aim to recruit 12 participants over 18-years-old over 12 months at the John Radcliffe Hospital, who are undergoing renal denervation therapy for resistant hypertension. In Addition to their routine care we propose performing a CT scan immediately or soon after their procedure in order to detect acute changes indicative or thermal injury to the fat surrounding the renal nerves.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
24/SC/0194
Date of REC Opinion
4 Jul 2024
REC opinion
Favourable Opinion