What is the Purpose of this Study?
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of an experimental drug called AZD3427, given in addition to standard-of-care medication, in patients with heart failure and pulmonary hypertension due to underlying heart disease (known as Group 2 pulmonary hypertension). Researchers also want to better understand this disease and associated health problems. AZD3427 consists of the human hormone relaxin and immunoglobulin; it is expected to mimic potentially beneficial effects of relaxin on the circulatory system, which are observed in pregnant women. AZD3427 has the possibility of improving functioning of the diseased heart. Study procedures include echocardiograms, right heart catheterizations, clinic visits, and drug injections.
Eligibility
- 1. Participant must be ≥ 18 years of age inclusive.
- 2. Participants must have a pre-existing diagnosis of HF, NYHA function class (FC) II to IV, and a pre-existing diagnosis of PH-LHD or likely or intermediate probability of Pulmonary hypertension due to left heart disease (PH-LHD) as per 2022 Pulmonary hypertension due to left heart disease European Society of Cardiology/European Respiratory Society (ESC/ERS) guidelines. Participants must be on stable HF standard of care medication, including diuretics.
- 3. Participants must have a combination of echocardiographic parameters that show intermediate or high probability of PH as per 2022 ESC/ERS guidelines.
- 4. Participants must have an on-study elevated pulmonary artery pressure from RHC performed as per RHC manual provided by the Sponsor, at Screening Visit 2:
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
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