Dose-ranging Study of AZD3427 in Participants with Heart Failure and Pulmonary Hypertension
Research type
Research Study
Full title
A Phase IIb Randomised, Double-blind, Placebo-controlled, Multi-centre, Dose-ranging Study of AZD3427 in Participants with Heart Failure and Pulmonary Hypertension due to Left Heart Disease (WHO Group 2)
IRAS ID
1007304
Contact name
Claudia Percivalle
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-502382-25
Clinicaltrials.gov Identifier
Research summary
This study is being conducted in patients with heart failure and pulmonary hypertension due to underlying heart disease (known as Group 2 pulmonary hypertension). Pulmonary hypertension Group 2 increases mortality and reduces exercise capacity. These patients live with significantly limited physical activity and quality of life despite optimal guideline-directed management. Currently, there is no dedicated treatment for this group of patients.
The study intervention AZD3427 consists of human hormone relaxin and immunoglobulin and is expected to mimic beneficial effects of relaxin on the circulatory system, which are observed in pregnant women. AZD3427 is designed to work by relaxing the blood vessels, making it easier for blood to flow. Researchers think that by relaxing the blood vessels in the lungs, the pulmonary vascular resistance (PVR) will go down. PVR is a way to measure how hard the heart has to work to pump blood through the lungs. Decreased PVR could lead to decreased pulmonary hypertension and improved heart function as well.
220 participants will be randomised to AZD3427 or placebo, such that approximately 188 evaluable participants complete the study. The study will be conducted in approximately 60 study centres across an estimated 15 countries.
Sponsor Name: AstraZeneca ABREC name
London - Central Research Ethics Committee
REC reference
23/LO/0286
Date of REC Opinion
13 Oct 2023
REC opinion
Further Information Favourable Opinion