A Phase IIb Study of AZD5462 in Patients With Chronic Heart Failure

RECRUITING

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The main purpose of this study is to evaluate the effect of AZD5462 on cardiac function in participants with chronic heart failure (HF).

Conditions:

🦠 Chronic Heart Failure

🗓️ Study Start (Actual) 4 June 2024

🗓️ Primary Completion (Estimated) 24 November 2025

✅ Study Completion (Estimated) 24 November 2025

👥 Enrollment (Estimated) 360

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE2

Locations:

📍 Alexander City, Alabama, United States

📍 Northridge, California, United States

📍 Torrance, California, United States

📍 Vista, California, United States

📍 Miami Beach, Florida, United States

📍 Miami, Florida, United States

📍 Richmond, Indiana, United States

📍 Boston, Massachusetts, United States

📍 Buffalo, New York, United States

📍 Rosedale, New York, United States

📍 Chapel Hill, North Carolina, United States

📍 Knoxville, Tennessee, United States

📍 Manassas, Virginia, United States

📍 Pleven, Bulgaria

📍 Sofia, Bulgaria

📍 Brno, Czechia

📍 Jaromer, Czechia

📍 Liberec 2, Czechia

📍 Louny, Czechia

📍 Ostrava-Dubina, Czechia

📍 Plzen - Bory, Czechia

📍 Aalborg, Denmark

📍 Herning, Denmark

📍 Balatonfüred, Hungary

📍 Budapest, Hungary

📍 Kistarcsa, Hungary

📍 Nyíregyháza, Hungary

📍 Székesfehérvár, Hungary

📍 Kochi, India

📍 Kolkata, India

📍 Surat, India

📍 Fukui-shi, Japan

📍 Higashiohmi-shi, Japan

📍 Kitakyushu, Japan

📍 Kobe, Japan

📍 Kumamoto, Japan

📍 Miyazaki-shi, Japan

📍 Morioka-shi, Japan

📍 Naha, Japan

📍 Omihachiman-shi, Japan

📍 Shunan, Japan

📍 Breda, Netherlands

📍 Deventer, Netherlands

📍 Enschede, Netherlands

📍 Kraków, Poland

📍 Warszawa, Poland

📍 Wrocław, Poland

📍 Łódź, Poland

📍 Bratislava, Slovakia

📍 Kosice, Slovakia

More locations available...

📋 Eligibility Criteria

Description

Inclusion Criteria:

* Participants must have a pre-existing diagnosis of HF NYHA FC II to IV.
* Participants must be on stable HF standard of care medication for at least 4 weeks prior to Screening.
* Minimum body mass index (BMI) of 18 kilograms per meter square (kg/m\^2) at Screening.
* For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential.
* All male participants should refrain from fathering a child or donating sperm until 3 months after the final study Follow-up Visit. Non-sterilised male participants should avoid fathering a child either by true abstinence or use of a condom for all sexual intercourse with a female partner of childbearing potential from the first dose until 3 months after the final Follow-up Visit.

Exclusion Criteria:

* Historical or current evidence of a clinically significant disease or disorder including, but not limited to:
1. Myocardial infarction, stroke, transient ischaemic attack, coronary artery bypass grafting, or percutaneous coronary intervention within 12 weeks prior to Screening or transcatheter structural heart interventions or cardiac valve surgery within 6 months prior to Screening.
2. Sarcoidosis, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic (obstructive) cardiomyopathy.
3. History of untreated clinically significant valve disease or a Screening confirmation of severe aortic stenosis, severe mitral stenosis, moderate or severe aortic insufficiency or severe mitral insufficiency.
4. Amyloidosis, Fabry disease, or haemochromatosis.
5. Pericardial disease (i.e., visually significant white pericardium on echocardiogram).
6. Known coagulation disorders.
7. Current diagnosis of active hepatitis.
8. Severe pulmonary disease that is not expected to improve over time, as assessed by the investigator.
9. Decompensated HF or any cardiopulmonary hospitalisation within 4 weeks prior to Screening.
10. History of active malignancy within 2 years, except for fully excised or treated basal cell carcinoma, or ≤ 2 squamous cell carcinomas of the skin and participants who are under investigation for breast or cervical cancer, including participants with a pap smear of grade ≥ 3.
* History of hypersensitivity to drugs with a similar chemical structure or class to AZD5462 or any component of AZD5462 drug product.
* Known history of drug or alcohol abuse within 24 months of Screening.
* Congenital long QT syndrome or history of QT prolongation associated with other medications that required discontinuation of that medication.
* Cardiac ventricular arrhythmia that requires treatment.
* History of or anticipated heart transplant.
* Current or planned bi-ventricular assist device implantation.
* Any planned highly invasive cardiovascular procedure (eg, coronary revascularisation, ablation of atrial fibrillation/flutter etc).
* Positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody at Screening.
* Known to have historically tested positive for Human immunodeficiency virus.

Ages Eligible for Study: 18 Years to 85 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 16 February 2024
First Submitted that Met QC Criteria 1 March 2024
First Posted 8 March 2024

Study Record Updates

Last Update Submitted that Met QC Criteria 1 July 2024
Last Update Posted 3 July 2024
Last Verified June 2024