What side effects are associated with this type of intervention?

Common treatments for heart failure include ACE inhibitors, ARBs, beta-blockers, and diuretics. ACE inhibitors and ARBs can cause side effects such as cough, elevated blood potassium levels, low blood pressure, and kidney dysfunction. Beta-blockers may lead to fatigue, cold extremities, weight gain, and depression. Diuretics can cause electrolyte imbalances, dehydration, and kidney dysfunction. It is important to monitor for these side effects and discuss any concerns with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of heart failure, including ACE inhibitors (e.g., enalapril), beta-blockers (e.g., metoprolol), ARBs (e.g., losartan), and mineralocorticoid receptor antagonists (e.g., spironolactone). More recently, SGLT2 inhibitors (e.g., dapagliflozin) and neprilysin inhibitors combined with ARBs (e.g., sacubitril/valsartan) have been approved for heart failure treatment. These drugs target various pathways involved in heart failure pathophysiology, such as neurohormonal activation, fluid overload, and myocardial remodeling. The trial AZD4831 is investigating a novel agent for heart failure with preserved ejection fraction (HFpEF), a condition for which treatment options are currently limited.

What other types of research exist?

Promising novel alternatives to AZD4831 for heart failure patients include: 1) SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) which have shown benefits in heart failure with reduced and preserved ejection fraction. 2) Vericiguat, a soluble guanylate cyclase stimulator, which has demonstrated efficacy in reducing heart failure-related hospitalizations and cardiovascular death. 3) Omecamtiv mecarbil, a cardiac myosin activator, which improves cardiac contractility and has shown positive outcomes in heart failure patients. These therapies offer novel mechanisms of action and have demonstrated promising results in clinical trials.

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AZD4831 for Heart Failure (ENDEAVOR Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Part A: ≥ 40 to ≤ 85 years of age, documented stable symptomatic HF (NYHA Class II-IV) for at least 1 month, LVEF > 40%, 6MWD ≥ 30 meters and ≤ 400 meters, KCCQ-TSS ≤ 90 points, NT-proBNP criteria based on BMI, presence of structural heart disease or specific echocardiogram findings, and no HF decompensation within 6 months before Randomisation

Part A: Male or female of non-childbearing potential

Must not have

Part A: eGFR < 30 mL/min/1.73m2, systolic blood pressure < 90 mmHg or ≥ 160 mmHg, heart rate > 110 bpm or < 50 bpm, life expectancy < 3 years due to other reasons than cardiovascular disease, history or ongoing allergy/hypersensitivity reactions to drugs, presence of any disease or condition limiting exercise capacity, current decompensated HF and/or NT-proBNP > 5000 pg/mL, documented history of ejection fraction ≤ 40%, planned cardiovascular procedure, recent cardiac events, Hb < 110 g/L (male) and < 100 g/L (female), thyroid disorders, elevated liver enzymes, pulmonary arterial hypertension, severe pulmonary disease, active infection, signs or confirmation of COVID-19 infection, concomitant medications known to be potent CYP3A4 inducers or inhibitors, and previous enrolment and randomisation in the present study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 29, day 85, day 113, day 169, day 336, day 365

Summary

This trial is testing a new medication called AZD4831 to see if it can help people with a certain type of heart failure. The study will include people whose hearts pump less efficiently but still have some function left. Researchers want to find out if this medication can improve how well their hearts work and make them feel better.

Who is the study for?

Adults aged 40-85 with stable heart failure, not recently worsened, who can walk a bit but not too far and have a left ventricular ejection fraction over 40%. They should be of non-childbearing potential and have a body mass index between 18.0 to 45.0 kg/m2. Excluded are those with severe kidney issues, very low or high blood pressure or heart rate, short life expectancy due to other diseases, allergies to drugs, conditions affecting exercise ability, recent heart problems or certain blood levels outside the normal range.

What is being tested?

The trial is testing AZD4831 against a placebo in people with specific types of heart failure. It's split into two parts: Part A (660 participants) and Part B (820 participants), each lasting up to 48 weeks. The study aims to see if AZD4831 is effective and safe for these patients by comparing it blindly—neither doctors nor patients know who gets the real drug.

What are the potential side effects?

While the side effects for AZD4831 aren't specified here, common side effects in trials like this may include nausea, headache, dizziness or fatigue. Since it's being tested on heart failure patients specifically, monitoring for worsening symptoms related to their condition would also be important.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You are between 40 and 85 years old, have had stable symptoms of heart failure for at least 1 month, and meet specific criteria for heart function and exercise capacity.

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I am either a man or a woman who cannot become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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Criterion: You have severe kidney problems, high or low blood pressure, fast or slow heart rate, a short life expectancy due to reasons other than heart disease, allergies to certain medications, conditions that limit physical activity, heart failure, low levels of hemoglobin, certain thyroid or liver disorders, severe lung or heart disease, ongoing infections, taking specific medications affecting liver enzymes, or have participated in this study before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 29, day 85, day 113, day 169, day 336, day 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 29, day 85, day 113, day 169, day 336, day 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 29, day 85, day 113, day 169, day 336, day 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Kansas City Cardiomyopathy Questionnaire -Total Symptom Score

Secondary study objectives

High sensitivity CRP (hsCRP)

Interleukin 6 (IL-6)

Kansas City Cardiomyopathy Questionnaire-Total Symptom Score

+6 more

Other study objectives

AZD4831 Pharmacokinetics

Adverse Events

Clinical Laboratory

+3 more

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B Dose based on Part AExperimental Treatment1 Intervention

AZD4831 Dose based on Part A

Group II: Part A 5 mgExperimental Treatment1 Intervention

AZD4831 5 mg

Group III: Part A 2.5 mgExperimental Treatment1 Intervention

AZD4831 2.5 mg

Group IV: Part A PlaceboPlacebo Group1 Intervention

Placebo

Group V: Part B PlaceboPlacebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD4831

2022

Completed Phase 3

~990

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart failure include ACE inhibitors, which relax blood vessels and reduce blood pressure; beta-blockers, which slow the heart rate and reduce the heart's workload; diuretics, which help remove excess fluid from the body; and mineralocorticoid receptor antagonists, which block the effects of aldosterone to reduce fluid retention and improve heart function. These treatments are essential for managing symptoms, improving quality of life, and reducing hospitalizations in heart failure patients. The trial AZD4831 is investigating a new treatment for heart failure with preserved ejection fraction (HFpEF), which may offer additional benefits by targeting specific pathways involved in heart failure.