{ "data": { "asOf": "2026-10-30T22:26:31.797Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT05737940", "title": "A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2", "scientificTitle": "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)", "status": "completed", "studyType": "interventional", "phase": [ "PHASE2" ], "conditions": [ "Pulmonary Hypertension (World Health Organization Group 2)", "Heart Failure" ], "interventions": [ { "name": "AZD3427", "type": "DRUG", "description": "The participants will receive AZD3427 SC injection single dose of either Dose A or Dose B or Dose C every 2 weeks for 24 weeks." }, { "name": "Placebo", "type": "DRUG", "description": "The participants will receive SC injection of placebo single dose every 2 weeks for 24 weeks." } ], "sponsor": { "name": "AstraZeneca", "type": "INDUSTRY" }, "locations": [ { "city": "Beverly Hills", "country": "United States", "facility": "Research Site" }, { "city": "La Jolla", "country": "United States", "facility": "Research Site" }, { "city": "New Haven", "country": "United States", "facility": "Research Site" }, { "city": "Baltimore", "country": "United States", "facility": "Research Site" }, { "city": "St Louis", "country": "United States", "facility": "Research Site" }, { "city": "Omaha", "country": "United States", "facility": "Research Site" }, { "city": "Rock Hill", "country": "United States", "facility": "Research Site" }, { "city": "Linz", "country": "Austria", "facility": "Research Site" }, { "city": "Vienna", "country": "Austria", "facility": "Research Site" }, { "city": "Edmonton", "country": "Canada", "facility": "Research Site" }, { "city": "Vancouver", "country": "Canada", "facility": "Research Site" }, { "city": "Halifax", "country": "Canada", "facility": "Research Site" }, { "city": "London", "country": "Canada", "facility": "Research Site" }, { "city": "Ottawa", "country": "Canada", "facility": "Research Site" }, { "city": "Toronto", "country": "Canada", "facility": "Research Site" }, { "city": "Montreal", "country": "Canada", "facility": "Research Site" }, { "city": "Beijing", "country": "China", "facility": "Research Site" }, { "city": "Changsha", "country": "China", "facility": "Research Site" }, { "city": "Guangzhou", "country": "China", "facility": "Research Site" }, { "city": "Kunming", "country": "China", "facility": "Research Site" }, { "city": "Prague", "country": "Czechia", "facility": "Research Site" }, { "city": "Prague", "country": "Czechia", "facility": "Research Site" }, { "city": "Prague", "country": "Czechia", "facility": "Research Site" }, { "city": "Aarhus", "country": "Denmark", "facility": "Research Site" }, { "city": 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"Research Site" }, { "city": "Nagoya", "country": "Japan", "facility": "Research Site" }, { "city": "Sapporo", "country": "Japan", "facility": "Research Site" }, { "city": "Sunto-gun", "country": "Japan", "facility": "Research Site" }, { "city": "Toyama", "country": "Japan", "facility": "Research Site" }, { "city": "Deventer", "country": "Netherlands", "facility": "Research Site" }, { "city": "Heerlen", "country": "Netherlands", "facility": "Research Site" }, { "city": "Tilburg", "country": "Netherlands", "facility": "Research Site" }, { "city": "Bialystok", "country": "Poland", "facility": "Research Site" }, { "city": "Gdansk", "country": "Poland", "facility": "Research Site" }, { "city": "Krakow", "country": "Poland", "facility": "Research Site" }, { "city": "Warsaw", "country": "Poland", "facility": "Research Site" }, { "city": "Warsaw", "country": "Poland", "facility": "Research Site" }, { "city": "Wroclaw", "country": "Poland", "facility": "Research Site" }, { "city": "Majadahonda", "country": "Spain", "facility": "Research Site" }, { "city": "Seville", "country": "Spain", "facility": "Research Site" }, { "city": "Toledo", "country": "Spain", "facility": "Research Site" }, { "city": "Valencia", "country": "Spain", "facility": "Research Site" }, { "city": "Gothenburg", "country": "Sweden", "facility": "Research Site" }, { "city": "Huddinge", "country": "Sweden", "facility": "Research Site" }, { "city": "Cambridge", "country": "United Kingdom", "facility": "Research Site" }, { "city": "Clydebank", "country": "United Kingdom", "facility": "Research Site" }, { "city": "London", "country": "United Kingdom", "facility": "Research Site" } ], "outcomes": { "other": [ "Number of Participants With Adverse Events and Serious Adverse Events" ], "primary": [ "Change From Baseline in Pulmonary Vascular Resistance (PVR)" ], "secondary": [ "Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP)", "Change From Baseline in Pulmonary Artery Wedge Pressure (PAWP)", "Change From Baseline in Cardiac Output (CO) ECHO", "Change From Baseline in Left Ventricular Stroke Volume (LV SV)", "Change From Baseline in Left Ventricular Ejection Fraction (LVEF)", "Change From Baseline in Left Ventricular Global Longitudinal Strain (LVGLS)", "Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP)", "Change From Baseline in Right Ventricle/Left Ventricle (RV/LV) Ratio", "Change From Baseline in Right Ventricular Outflow Tract Acceleration Time (RVOT AT)", "Change From Baseline in Tricuspid Regurgitation Velocity (TRV)", "Change From Baseline in TAPSE/PASP [Tricuspid Annular Plane Systolic Excursion/ Pulmonary Arterial Systolic Pressure]", "Change From Baseline in Systemic Vascular Resistance (SVR)", "Change From Baseline in 6-minute Walking Distance (6MWD)", "Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS)", "Number of Participants With Improved Change From Baseline in New York Heart Association Functional Class (NYHA FC)", "Change From Baseline in Serum Creatinine", "Change From Baseline in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP)", "Change From Baseline in Cystatin C", "Change From Baseline in eGFR (Estimated Glomerular Filtration Rate)", "AZD3427 Serum Concentration", "Number of Participants With Presence of Anti-drug Antibodies (ADAs)", "Evaluation of Positive ADA Titer" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion criteria:\n\n1. Participant must be ≥ 18 years of age inclusive.\n2. 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.\n3. Participants must have a combination of echocardiographic parameters that show intermediate or high probability of PH as per 2022 ESC/ERS guidelines.\n4. 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:\n\n 1. PAWP ≥ 15 mmHg\n 2. mPAP ≥ 20 mmHg\n5. Minimum body weight of 45 kg (inclusive).\n6. Capable and willing of giving signed informed consent.\n\nExclusion Criteria\n\n1. Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.\n2. Historical or current evidence of a clinically significant disease or disorder.\n3. Decompensated HF or hospitalisation due to decompensated HF.\n4. Any contraindications to RHC.\n5. History of hypersensitivity to SC injections or devices.\n6. 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.\n7. Known lung disease with Forced expiratory volume in the first second (FEV1) \\< 30% of predicted.\n8. Congenital long QT syndrome.\n9. Cardiac ventricular arrhythmia which requires treatment. Participants with atrial fibrillation or flutter and controlled ventricular rate are permitted.\n10. History of or anticipated heart transplant or ventricular assist device implantation.\n11. Any known planned (scheduled) highly invasive Cardiovascular (CV) procedure (eg, coronary revascularisation, ablation of atrial fibrillation/flutter, valve repair/replacement, aortic aneurysm surgery, etc).\n12. 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