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

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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

Conditions:

🦠 Pulmonary Hypertension (World Health Organization Group 2) 🦠 Heart Failure

🗓️ Study Start (Actual) 24 April 2023

🗓️ Primary Completion (Estimated) 23 April 2025

✅ Study Completion (Estimated) 2 June 2025

👥 Enrollment (Estimated) 220

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE2

Locations:

📍 Beverly Hills, California, United States

📍 La Jolla, California, United States

📍 Los Angeles, California, United States

📍 New Haven, Connecticut, United States

📍 Baltimore, Maryland, United States

📍 Saint Louis, Missouri, United States

📍 Omaha, Nebraska, United States

📍 Rock Hill, South Carolina, United States

📍 Eisenstadt, Austria

📍 Linz, Austria

📍 Wien, Austria

📍 Edmonton, Alberta, Canada

📍 Vancouver, British Columbia, Canada

📍 Halifax, Nova Scotia, Canada

📍 London, Ontario, Canada

📍 Ottawa, Ontario, Canada

📍 Toronto, Ontario, Canada

📍 Montreal, Quebec, Canada

📍 Beijing, China

📍 Changsha, China

📍 Guangzhou, China

📍 Kunming, China

📍 Praha 10, Czechia

📍 Praha 2, Czechia

📍 Praha 4, Czechia

📍 Aarhus, Denmark

📍 Copenhagen, Denmark

📍 Berlin, Germany

📍 Cologne, Germany

📍 Frankfurt, Germany

📍 Jena, Germany

📍 Brescia, Italy

📍 Genoa, Italy

📍 Marche, Italy

📍 Milano, Italy

📍 Milan, Italy

📍 Trieste, Italy

📍 Kasugai-shi, Japan

📍 Kure-shi, Japan

📍 Matsumoto-shi, Japan

📍 Nagoya-shi, Japan

📍 Okayama, Japan

📍 Sapporo-shi, Japan

📍 Sunto-gun, Japan

📍 Toyama-shi, Japan

📍 Deventer, Netherlands

📍 Heerlen, Netherlands

📍 Tilburg, Netherlands

📍 Białystok, Poland

📍 Gdansk, Poland

📍 Krakow, Poland

📍 Warszawa, Poland

📍 Wrocław, Poland

📍 Majadahonda, Spain

📍 Sevilla, Spain

📍 Toledo, Spain

📍 Valencia, Spain

📍 Göteborg, Sweden

📍 Huddinge, Sweden

📍 Cambridge, United Kingdom

📍 Clydebank, United Kingdom

📍 London, United Kingdom

More locations available...

📋 Eligibility Criteria

Description

Inclusion Criteria:

1. Participant must be ≥ 18 years of age inclusive.
2. 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.
3. Participants must have a combination of echocardiographic parameters that show intermediate or high probability of PH as per 2022 ESC/ERS guidelines.
4. 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:
1. PAWP ≥ 15 mmHg
2. mPAP ≥ 20 mmHg
5. Minimum body weight of 45 kg (inclusive).
6. Capable and willing of giving signed informed consent.
Exclusion Criteria
1. Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
2. Historical or current evidence of a clinically significant disease or disorder.
3. Decompensated HF or hospitalisation due to decompensated HF.
4. Any contraindications to RHC.
5. History of hypersensitivity to SC injections or devices.
6. 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.
7. Known lung disease with Forced expiratory volume in the first second (FEV1) \< 30% of predicted.
8. Congenital long QT syndrome.
9. Cardiac ventricular arrhythmia which requires treatment. Participants with atrial fibrillation or flutter and controlled ventricular rate are permitted.
10. History of or anticipated heart transplant or ventricular assist device implantation.
11. Any known planned (scheduled) highly invasive Cardiovascular (CV) procedure (eg, coronary revascularisation, ablation of atrial fibrillation/flutter, valve repair/replacement, aortic aneurysm surgery, etc).
12. Participants who have previously received AZD3427.

Ages Eligible for Study: 18 Years to 130 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 20 January 2023
First Submitted that Met QC Criteria 17 February 2023
First Posted 21 February 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 10 July 2024
Last Update Posted 11 July 2024
Last Verified July 2024