A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2 (NCT05737940) | Clinical Trial Compass
CompletedPhase 2
A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2
United States260 participantsStarted 2023-04-24
Plain-language summary
This study is intended to assess the ability of AZD3427 to reduce pulmonary vascular resistance (PVR) after 24 weeks of treatment in participants with heart failure (HF) and pulmonary hypertension (PH) Group 2
Who can participate
Age range18 Years – 130 Years
SexALL
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Inclusion criteria
✓. Participant must be ≥ 18 years of age inclusive.
✓. 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.
✓. Participants must have a combination of echocardiographic parameters that show intermediate or high probability of PH as per 2022 ESC/ERS guidelines.
✓. 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:
✓. PAWP ≥ 15 mmHg
✓. mPAP ≥ 20 mmHg
✓. Minimum body weight of 45 kg (inclusive).
✓. Capable and willing of giving signed informed consent.
Exclusion criteria
✕. Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
✕. Historical or current evidence of a clinically significant disease or disorder.
✕. Decompensated HF or hospitalisation due to decompensated HF.
What they're measuring
1
Change from baseline in Pulmonary Vascular Resistance (PVR)
✕. History of hypersensitivity to SC injections or devices.
✕. History of hypersensitivity to drugs with a similar chemical structure or class to AZD3427 or any component of AZD3427 drug product, or ongoing clinically important allergy/hypersensitivity.
✕. Known lung disease with Forced expiratory volume in the first second (FEV1) \< 30% of predicted.