← Back to all trials
Not Yet Recruiting
NCT05737940
A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2
Conditions: Pulmonary Hypertension (World Health Organization Group 2), Heart Failure
Sex: All
Ages: 18 Years – 130 Years
Phase: PHASE2
Enrollment: 220
Sponsor: AstraZeneca
Summary
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.
Eligibility Criteria
Inclusion criteria: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 mmHgmPAP ≥ 20 mmHgMinimum body weight of 50 kg (inclusive).Capable of giving signed informed consent.Exclusion CriteriaDiagnosis 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.
Source: ClinicalTrials.gov (NCT05737940). StuddyBuddy aggregates publicly available trial information.