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

Description

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 Overview

Study Details

Study overview

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

A Phase IIb Two-Cohort, Randomised, Placebo-controlled, Double-blind, Multi-centre, Dose-ranging Study of AZD5462 in Stable Patients With Chronic Heart Failure

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

Condition
Chronic Heart Failure
Intervention / Treatment

-

Contacts and Locations

Alexander City

Research Site, Alexander City, Alabama, United States, 35010

Northridge

Research Site, Northridge, California, United States, 91325

Torrance

Research Site, Torrance, California, United States, 90502

Vista

Research Site, Vista, California, United States, 92081

Miami Beach

Research Site, Miami Beach, Florida, United States, 33140

Miami

Research Site, Miami, Florida, United States, 33133

Richmond

Research Site, Richmond, Indiana, United States, 47374

Boston

Research Site, Boston, Massachusetts, United States, 02114

Buffalo

Research Site, Buffalo, New York, United States, 14215

Rosedale

Research Site, Rosedale, New York, United States, 11422

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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 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, 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2025-11-24