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

Phase 2

Recruiting

• Conditions: Heart Failure and Pulmonary Hypertension due to Left Heart Disease (WHO Group 2)

• Registration Number: JPRN-jRCT2041230006
• Lead Sponsor: Ageishi Yuji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion 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/ESR 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

Exclusion 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. History of greater than moderate mitral or aortic regurgitation valvular disease 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified