ACTIVE_NOT_RECRUITING

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

Conditions

Chronic Heart Failure Relaxin Family Peptide Receptor 1 (RXFP1) agonist

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-06-04

Study Completion:2026-02-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06299826

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.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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, 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.

Inclusion Criteria

Exclusion 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, 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.

Contacts and Locations

Study Locations (Sites)

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 Beach, Florida, 33140

United States

Research Site

Miami, Florida, 33133

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

Knoxville, Tennessee, 37916

United States

Research Site

Manassas, Virginia, 20109

United States

Collaborators and Investigators

Sponsor: AstraZeneca

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

Study Start Date2024-06-04

Study Completion Date2026-02-12

Study Record Updates

Study Start Date2024-06-04

Study Completion Date2026-02-12

Terms related to this study

Keywords Provided by Researchers

Relaxin Family Peptide Receptor 1 (RXFP1) agonist

Additional Relevant MeSH Terms

Chronic Heart Failure