A Phase IIb Study of AZD3427 in Participants with Heart Failure and Pulmonary Hypertension Group 2

JRCT ID: jRCT2041230006

Registered date:13/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart Failure and Pulmonary Hypertension due to Left Heart Disease (WHO Group 2)
• Date of first enrollment: 02/06/2023
• Target sample size: 20
• Countries of recruitment: Austria,Japan,Canada,Japan,China,Japan,Czech Republic,Japan,Germany,Japan,Denmark,Japan,Spain,Japan,United Kingdom,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,Sweden,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Subjects will be randomized to four dosing groups to receive subcutaneous injections of AZD3427 (Low, medium and high dose) or placebo every 2 weeks for 24 weeks.

Outcome(s)

• Primary Outcome: Change in Pulmonary vascular resistance(PVR) from baseline to Week 25 compared with placebo, as measured by RHC.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Participants must have a pre-existing diagnosis of Heart failure(HF), NYHA FC II to IV, and a pre-existing diagnosis of Pulmonary hypertension due to left heart disease(PH-LHD) or likely or intermediate probability of PH-LHD as per 2022 ESC/ERS guidelines. Participants must be on stable HF standard
of care medication, including diuretics, for at least 4 weeks prior to Screening.

- Participants must have an on-study elevated pulmonary artery pressure from Right heart catheterisation(RH
C) performed at Screening:

(a) Pulmonary artery wedge pressure(PAWP) is 15 mmHg or more

(b) Mean pulmonary arterial pressure(mPAP) is 20 mmHg or more

Exclude criteria

- Diagnosis of PH in WHO Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.

- Historical or current evidence of a clinically significant disease or disorder including, but not limited to:

(a) Myocardial infarction, stroke, transient ischaemic attack, coronary artery bypass grafting, percutaneous coronary intervention, implantable cardioverter defibrillator implantation (implanted standard pacemaker or CRT-P are not exclusionary), within 12 weeks prior to Screening.

(b) Sarcoidosis, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, complex congenital heart disease. Greater than moderate mitral or aortic valve regurgitation or greater than mild aortic or mitral stenosis. Severe tricuspid regurgitation due to primary valvular disease, eg, from endocarditis or mechanical destruction.

(c) Any history of pulmonary embolism or deep vein thrombosis in the last 12 months.

(d) Known coagulation disorders.

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT05737940