← Back to Search

Other

AZD5462 for Heart Failure (LUMINARA Trial)

Phase 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Historical or current evidence of a clinically significant disease or disorder including myocardial infarction, stroke, transient ischaemic attack, coronary artery bypass grafting, or percutaneous coronary intervention within 12 weeks prior to Screening, transcatheter structural heart interventions or cardiac valve surgery within 6 months prior to Screening, sarcoidosis, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, untreated clinically significant valve disease, severe aortic stenosis, severe mitral stenosis, moderate or severe aortic insufficiency, severe mitral insufficiency, amyloidosis, Fabry disease, haemochromatosis, pericardial disease, coagulation disorders, active hepatitis, severe pulmonary disease not expected to improve over time, decompensated HF or any cardiopulmonary hospitalisation within 4 weeks prior to Screening, history of active malignancy within 2 years except for fully excised or treated basal cell carcinoma, or ≤ 2 squamous cell carcinomas of the skin, participants under investigation for breast or cervical cancer, 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, cardiac ventricular arrhythmia requiring treatment, history of or anticipated heart transplant, current or planned bi-ventricular assist device implantation, any planned highly invasive cardiovascular procedure, positive hepatitis C antibody, hepatitis B virus surface antigen, hepatitis B virus core antibody at Screening, known to have historically tested positive for Human immunodeficiency virus.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15 (week 3), day 29 (week 5) and 85 (week 13)

Summary

"This trial aims to see how a medication called AZD5462 affects the heart function of people with chronic heart failure."

Who is the study for?
This trial is for individuals with chronic heart failure (NYHA FC II to IV) who have been on stable heart medications for at least 4 weeks. Participants must have a BMI of at least 18 and agree to contraception or abstinence measures during the study and for three months after.
What is being tested?
The study tests AZD5462's effects on cardiac function in chronic heart failure patients, comparing it against a placebo. The goal is to see if AZD5462 can improve heart performance.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with new heart medications may include dizziness, changes in blood pressure, kidney function alterations, electrolyte imbalances, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with heart failure that affects my daily activities.
Select...
I have been on stable heart failure medication for at least 4 weeks.
Select...
I am not pregnant, breastfeeding, and cannot become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had significant heart, liver, or lung issues, or cancer in the last 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 15 (week 3), day 29 (week 5) and 85 (week 13)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 15 (week 3), day 29 (week 5) and 85 (week 13) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cohort A and B: Change from Baseline in Echocardiography Parameters
Secondary study objectives
Cohorts A and B : Plasma Concentration of AZD5462
Cohorts A and B: Change from Baseline in Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS)
Cohorts A and B: Change from Baseline in New York Heart Association Functional Class (NYHA FC)
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort A & B: PlaceboExperimental Treatment1 Intervention
Participants will receive matching placebo OD tablets for 24 weeks.
Group II: Cohort A & B: AZD5462 medium doseExperimental Treatment1 Intervention
Participants will receive medium dose of AZD5462 as OD tablets for 24 weeks.
Group III: Cohort A & B: AZD5462 low doseExperimental Treatment1 Intervention
Participants will receive low dose of AZD5462 as OD tablets for 24 weeks.
Group IV: Cohort A & B: AZD5462 high doseExperimental Treatment1 Intervention
Participants will receive high dose of AZD5462 as OD tablets for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD5462
2022
Completed Phase 1
~150
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,121,343 Total Patients Enrolled
~240 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top