An Exploratory Haemodynamic Study in Patients With Compensated Cirrhosis and Portal Hypertension

What Was Tested

In this phase 2 trial, researchers set out to test Terlipressin and Relaxin (Serelaxin).

The main purpose of this exploratory study was to investigate the effect of serelaxin (RLX030) infusion on the hepatic and renal circulation in patients with compensated cirrhosis and portal hypertension.

Measurements were acquired non-invasively using magnetic resonance angiography (MRA) (study part A) and more directly via cannulation of the hepatic portal vein during a routine transjugular intrahepatic portosystemic shunt (TIPSS) check procedure (study part B), to determine the acute haemodynamic response to serelaxin (RLX030).

It had three arms (groups): Part A: Terlipressin acetate (experimental), Part A: Serelaxin (RLX030) (experimental) and Part B Serelaxin (RLX030) (experimental).

The registry classes the interventions as drug.

Who Took Part

47 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Cirrhosis of alcohol aetiology according to physician's assessment prior to screening. Cirrhosis with clinical and/or endoscopic evidence of portal hypertension (e.g. oesophageal varices). Cirrhosis with TIPSS in situ and PPG\>5mmHg. Fully functioning TIPSS without variceal filling as confirmed by portography.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: use of any drug to treat portal hypertension (e.g. vasodilators such as non-selective beta blockers or nitrates) within 1 month prior to screening; decompensated cirrhosis (child-pugh score \>9 points, and/or ascites requiring diuretics, and/or hepatic encephalopathy) at visit 1; BMI (weight\[kg\] / height\[m\^2\]) \> 40 kg/m\^2.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Terlipressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Terlipressin group and the comparison group ran side by side rather than switching.

Everyone knew when Terlipressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-04 with completion listed for 2014-12.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Serelaxin Treatment Group Only)) (time frame: Baseline, 120 min post serelaxin infusion). Change From Baseline of the Portal Pressure Gradient (PPG) (Study Part B) (time frame: Baseline, 120 min post-infusion start).

It also tracked 7 secondary outcomes, for example Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Terlipressin Acetate Group Only)), Change From Baseline of the Blood Flow for the Hepatic Artery (Study Part A (Serelaxin Treatment Group Only)), Change From Baseline of the Blood Flow for the Descending Thoracic Aorta (Study Part A (Serelaxin Treatment Group Only)), Change From Baseline of the Blood Flow for the Portal Vein (Study Part A (Serelaxin Treatment Group Only)) and Change From Baseline of the Portal Vein Pressure (PVP) (Study Part B).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Terlipressin and Relaxin (Serelaxin) in 47 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Terlipressin compound page and the Relaxin (Serelaxin) compound page, all human trials.