A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Hypertension (World Health Organization Group 2), Heart Failure

In brief

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

Key facts

Study ID: NCT05737940
Run by: AstraZeneca
People needed: 260
Starts: 2023-04-24
Expected to finish: 2025-08-25
Last updated by the study team: 2025-09-24

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.
Any contraindications to RHC.
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.
Congenital long QT syndrome.
Cardiac ventricular arrhythmia which requires treatment. Participants with atrial fibrillation or flutter and controlled ventricular rate are permitted.
History of or anticipated heart transplant or ventricular assist device implantation.
Any known planned (scheduled) highly invasive Cardiovascular (CV) procedure (eg, coronary revascularisation, ablation of atrial fibrillation/flutter, valve repair/replacement, aortic aneurysm surgery, etc).
Participants who have previously received AZD3427.

Where it is running

Research Site — Kasugai-shi, Japan
Research Site — Kure-shi, Japan
Research Site — Nagoya, Japan
Research Site — Sapporo, Japan
Research Site — Sunto-gun, Japan
Research Site — Toyama, Japan
Research Site — Deventer, Netherlands
Research Site — Heerlen, Netherlands
Research Site — Tilburg, Netherlands
Research Site — Bialystok, Poland
Research Site — Gdansk, Poland
Research Site — Krakow, Poland
Research Site — Warsaw, Poland
Research Site — Warsaw, Poland
Research Site — Wroclaw, Poland
Research Site — Majadahonda, Spain
Research Site — Seville, Spain
Research Site — Toledo, Spain
Research Site — Valencia, Spain
Research Site — Gothenburg, Sweden
Research Site — Huddinge, Sweden
Research Site — Cambridge, United Kingdom
Research Site — Clydebank, United Kingdom
Research Site — London, United Kingdom
Research Site — Bunkyō City, Japan

Full record on ClinicalTrials.gov

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