Serelaxin To Lower Portal Pressure (STOPP) study
Research type
Research Study
Full title
Serelaxin To Lower Portal Pressure in Patients with Cirrhosis and Portal Hypertension (STOPP)
IRAS ID
187900
Contact name
Jonathan Fallowfield
Contact email
Sponsor organisation
University of Edinburgh
Eudract number
2015-004031-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 30 days
Research summary
Portal hypertension (an increase in blood pressure in the portal vein, which carries the blood from the intestine and spleen to the liver) underlies most of the serious complications of liver cirrhosis. In this randomised placebo-controlled study (STOPP) we aim to look at the effects of an investigational drug - serelaxin – on portal hypertension by measuring the blood pressure and blood flow in the liver after an infusion for 2 hours through a drip. Serelaxin is a manufactured form of relaxin, which is a naturally occurring protein (hormone) that has been shown in a number of studies in humans to have beneficial effects on the circulation, particularly in patients with heart failure. We have recently shown in a small study in people with cirrhosis and portal hypertension that serelaxin was safe and well tolerated and reduced pressure in the portal vein during a 2 hour short infusion. We wish to confirm this finding in a larger number of patients using the ‘gold standard’ test for measuring the effect of drugs on portal hypertension (hepatic venous pressure gradient, HVPG), and to also include a small placebo treated group to confirm that the effects of serelaxin are real and to eliminate any bias in the study by ensuring that participants and investigators do not know which treatment has been allocated (so called ‘double blind’ study). A reduction in the HVPG by >20% from baseline has been reported to improve clinical outcomes and will be the primary endpoint for the study. We will also measure the effects of serelaxin on liver blood flow, on heart function, and on the general circulation to better understand the way in which it works.
REC name
West of Scotland REC 1
REC reference
16/WS/0070
Date of REC Opinion
18 Apr 2016
REC opinion
Further Information Favourable Opinion