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New heart failure drug shows promise in Mid-Stage trial

NCT ID NCT06299826

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tested a new medicine called AZD5462 in 375 adults with stable chronic heart failure. The goal was to see if the drug could improve how well the heart pumps blood. Participants continued their usual heart failure medications while receiving either AZD5462 or a placebo. The trial is now complete, and results will help determine if the drug is safe and effective enough for larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

375 people

The number who actually took part.

Started

Jun 2024

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 consent and during the Screening period. * 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 consent or transcatheter structural heart interventions or cardiac valve surgery within 6 months prior to consent. 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, except planned hospitalisation without worsening of cardiac or pulmonary functions, within 4 weeks prior to consent or during the Screening period. 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 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 cardiac resynchronization therapy/bi-ventricular pacemaker or mechanical assist device implantation. * Any planned highly invasive cardiovascular procedure (eg, coronary revascularisation, ablation of atrial fibrillation/flutter etc). * Positive hepatitis C antibody, or hepatitis B virus surface antigen at Screening. Participants with positive hepatitis B virus core antibody can be included in the study as long as hepatitis B virus surface antigen is negative, and there are no other signs of an active hepatitis B. * Known to have historically tested positive for Human Immunodeficiency Virus.

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Conditions

The condition(s) this trial relates to.

congestive heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic heart failure

Contacts and locations

Locations

  • Research Site

    Alexander City, Alabama, 35010, United States

  • Research Site

    Northridge, California, 91325, United States

  • Research Site

    Torrance, California, 90502, United States

  • Research Site

    Vista, California, 92081, United States

  • Research Site

    Miami, Florida, 33133, United States

  • Research Site

    Miami Beach, Florida, 33140, United States

  • Research Site

    Richmond, Indiana, 47374, United States

  • Research Site

    Boston, Massachusetts, 02114, United States

  • Research Site

    Buffalo, New York, 14215, United States

  • Research Site

    Rosedale, New York, 11422, United States

  • Research Site

    Chapel Hill, North Carolina, 27599, United States

  • Research Site

    Philadelphia, Pennsylvania, 19107, United States

  • Research Site

    Knoxville, Tennessee, 37916, United States

  • Research Site

    Manassas, Virginia, 20109, United States

  • Research Site

    Pleven, 5800, Bulgaria

  • Research Site

    Pleven, 5803, Bulgaria

  • Research Site

    Sofia, 1309, Bulgaria

  • Research Site

    Sofia, 1431, Bulgaria

  • Research Site

    Sofia, 1527, Bulgaria

  • Research Site

    Brno, 625 00, Czechia

  • Research Site

    Jaroměř, 55101, Czechia

  • Research Site

    Liberec, 460 01, Czechia

  • Research Site

    Louny, 440 01, Czechia

  • Research Site

    Pilsen, 301 00, Czechia

  • Research Site

    Aalborg, 9000, Denmark

  • Research Site

    Herning, 7400, Denmark

  • Research Site

    Balatonfüred, 8230, Hungary

  • Research Site

    Kistarcsa, 2143, Hungary

  • Research Site

    Nyíregyháza, 4400, Hungary

  • Research Site

    Székesfehérvár, 8000, Hungary

  • Research Site

    Kochi, 682018, India

  • Research Site

    Kolkata, 700020, India

  • Research Site

    Surat, 395001, India

  • Research Site

    Vadodara, 390022, India

  • Research Site

    Fukui-shi, 910-8526, Japan

  • Research Site

    Higashiibaraki-gun, 311-3193, Japan

  • Research Site

    Higashiohmi-shi, 527-8505, Japan

  • Research Site

    Kitakyushu, 802-8555, Japan

  • Research Site

    Kobe, 654-0155, Japan

  • Research Site

    Kumamoto, 861-4193, Japan

  • Research Site

    Miyazaki, 880-0834, Japan

  • Research Site

    Morioka, 020-0066, Japan

  • Research Site

    Naha, 902-8511, Japan

  • Research Site

    Ōmihachiman, 523-0082, Japan

  • Research Site

    Shūnan, 745-8522, Japan

  • Research Site

    Breda, 4818 CK, Netherlands

  • Research Site

    Deventer, 7416 SE, Netherlands

  • Research Site

    Enschede, 7512 KZ, Netherlands

  • Research Site

    Krakow, 30-082, Poland

  • Research Site

    Krakow, 31-271, Poland

  • Research Site

    Lodz, 93-513, Poland

  • Research Site

    Warsaw, 01-249, Poland

  • Research Site

    Wroclaw, 50-556, Poland

  • Research Site

    Wroclaw, 53-114, Poland

  • Research Site

    Bratislava, 813 69, Slovakia

  • Research Site

    Bratislava, 821 07, Slovakia

  • Research Site

    Košice, 044 24, Slovakia

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