Heart Failure Clinical Trial
A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2
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.
This study is a randomized, placebo-controlled, multi-centre, dose-ranging study of AZD3427 in participants with heart failure and pulmonary hypertension due to left heart disease (World Health Organisation [WHO] Group 2).
Approximately 220 participants will be randomised to 4 treatment groups (in a 1:1:1:1 ratio) to receive a subcutaneous (SC) injection of AZD3427 or placebo every 2 weeks for 24 weeks.
This study will evaluate 3 dose levels of AZD3427: Dose A, Dose B, and Dose C. Dose modification is not applicable for this study.
The study will be conducted in approximately 60 study centres across an estimated 15 countries.
The study will include approximately 16 study visits: 2 visits during the Screening Period,13 visits during the Treatment Period, and one visit during the Follow-up Period.
The expected total duration of the study is 32 to 37 weeks, depending on the length of the Screening Period.
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/ESR) 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 50 kg (inclusive).
Capable of giving signed informed consent.
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 any hospitalisation.
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/Vital capacity (FEV1/VC) < 30%.
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.
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There are 46 Locations for this study
La Jolla California, 92093, United States
New Haven Connecticut, 06519, United States
Baltimore Maryland, 21287, United States
Saint Louis Missouri, 63136, United States
Omaha Nebraska, 68198, United States
Rock Hill South Carolina, 29732, United States
Eisenstadt , 7000, Austria
Linz , 4020, Austria
Wien , 1100, Austria
London Ontario, N6A 5, Canada
Ottawa Ontario, K1Y 4, Canada
Montreal Quebec, H1T 1, Canada
Beijing , 10003, China
Beijing , 10003, China
Changsha , 43003, China
Guangzhou , 51008, China
Kunming , 65005, China
Praha 10 , 10034, Czechia
Praha 2 , 12808, Czechia
Praha 4 , 140 2, Czechia
Aarhus , 8200, Denmark
Berlin , 13353, Germany
Cologne , 50937, Germany
Frankfurt , 60596, Germany
Jena , 07747, Germany
Brescia , 25123, Italy
Marche , 60126, Italy
Milano , 20142, Italy
Milan , 20138, Italy
Trieste , 34149, Italy
Kure-shi , 737-8, Japan
Matsumoto-shi , 390-8, Japan
Toyama-shi , 930-0, Japan
Deventer , 7416 , Netherlands
Heerlen , 6419 , Netherlands
Tilburg , 5022 , Netherlands
Białystok , 15-27, Poland
Gdansk , 80-95, Poland
Krakow , 31-20, Poland
Warszawa , 02-00, Poland
Warszawa , 04-62, Poland
Majadahonda , 28222, Spain
Sevilla , 41009, Spain
Toledo , 45007, Spain
Valencia , 46026, Spain
Clydebank , G81 4, United Kingdom
London , SW3 6, United Kingdom
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