Vall d'Hebron has participated in an international clinical trial for a new treatment for resistant hypertension

The Vall d'Hebron Research Institute (VHIR) and the Vall d'Hebron University Hospital have participated, together with the INCLIVA Health Research Institute of the Hospital Clínic Universitari de València, in an international multi-centre phase II clinical trial to analyse the efficacy of a monoclonal antibody in the treatment of resistant arterial hypertension. Monoclonal antibodies are laboratory-created proteins that bind to specific substances in the body, known as antigens, and are used to treat various diseases because of their ability to precisely target specific cells.

Hypertension is a major risk factor for heart disease and stroke worldwide. It contributes significantly to cardiovascular mortality and morbidity and causes damage to vital organs such as the retina (retinopathy) and kidneys (nephropathy).

Despite the availability of many effective anti-hypertensive drugs, a significant proportion of patients continue to experience treatment-resistant hypertension.

The main objective of this study was to evaluate the efficacy and dose-response relationship of the monoclonal antibody XXB750. This monoclonal antibody, which is a natriuretic peptide receptor 1 analogue, was administered every 4 weeks. Its effects were compared to those of a placebo, with a view to seeing if it helped to reduce ambulatory systolic blood pressure between the beginning of the study and week 12.

It was a multi-centre, randomised, double-blind, parallel-group study conducted over 20 weeks to find the appropriate dosage and assess the efficacy, safety and tolerability of this monoclonal antibody in patients with resistant hypertension.

The study, sponsored by Novartis, began in June 2022 and involved 153 centres from 18 countries, including Spain, France, Germany, Slovakia, Poland, Bulgaria, the United States, Japan and Australia. In addition to the Vall d'Hebron University Hospital, other Spanish centres such as INCLIVA and the Hospital 12 de Octubre also participated.

The principal investigator of the study at Vall d'Hebron was Dr Sheila Bermejo, member of the Nephrology Service of the Renal System Knowledge Area of Vall d'Hebron University Hospital and researcher of the Nephrology and Renal Transplantation Group at VHIR.

The principal investigator at INCLIVA-Hospital Clínic de València was Dr Fernando Martínez, member of the Cardiometabolic and Renal Risk Research Group, head of the Internal Medicine Section at Hospital Clínic and professor at the University of Valencia (UV). Dr María José Forner, head of the Internal Medicine Service and professor at the UV, and Dr Sara Vela, also of the Internal Medicine Service, also participated as sub-researchers in the same group.

Other participants included Alba Morales, trial coordinator of the Internal Medicine Service at INCLIVA, and the nurses Ana Belén González, Mirna Orgelán and Mario Bayo, all of whom are members of the Internal Medicine Service.

The next phase of the study will focus on ensuring a complete and accurate collection of data in order to draw robust and meaningful conclusions. A primary analysis of the data will then be carried out.