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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 29, day 85, day 113, day 169, day 336, day 365
Awards & highlights
ENDEAVOR Trial Summary
This trial will test a new drug for heart failure. It is double-blind, meaning neither the patients nor the doctors will know who is receiving the drug or the placebo. It is placebo-controlled, meaning that some patients will receive a placebo (a harmless pill with no active ingredient). The trial will be conducted at multiple centers.
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.Check my eligibility
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.See study design
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.
ENDEAVOR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
I am either a man or a woman who cannot become pregnant.
ENDEAVOR Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Kansas City Cardiomyopathy Questionnaire -Total Symptom Score
Secondary outcome measures
High sensitivity CRP (hsCRP)
Interleukin 6 (IL-6)
Kansas City Cardiomyopathy Questionnaire-Total Symptom Score
+6 moreOther outcome measures
AZD4831 Pharmacokinetics
Adverse Events
Clinical Laboratory
+3 moreENDEAVOR 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
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,274 Previous Clinical Trials
288,612,710 Total Patients Enrolled
84 Trials studying Heart Failure
165,315 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.My condition meets all the same requirements as Part A, except for those about life expectancy, heart failure cause, and lung issues.You must be 40-85 years old, have been diagnosed with symptomatic heart failure for at least 6 weeks, have a certain level of heart function, be able to walk a certain distance, and meet specific health assessment criteria based on your weight. You should also be unable to have children.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.I am either a man or a woman who cannot become pregnant.You must have a body mass index (BMI) between 18.0 and 45.0.
Research Study Groups:
This trial has the following groups:- Group 1: Part A Placebo
- Group 2: Part A 5 mg
- Group 3: Part B Placebo
- Group 4: Part A 2.5 mg
- Group 5: Part B Dose based on Part A
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people of all ages eligible to participate in this research?
"This particular clinical trial only accepts patients that are between 40-85 years old. In contrast, there are 25 trials for people under 18 and 728 trials for senior citizens."
Answered by AI
How can I sign up for the research project?
"With the aim of enrolling 1485 individuals, this clinical trial is open to heart failure patients aged 40-85."
Answered by AI
How many people fit the bill for this clinical trial's requirements?
"The clinicaltrials.gov website confirms that this study is still recruiting patients. 37 sites across the country are looking for a total of 1485 individuals to participate. The posting date was June 30th, 2021 and the most recent update was on November 17th, 2022."
Answered by AI
How many different hospitals are included in this clinical trial?
"To limit undue burdens on patients, the study's organizers have made an effort to make 37 clinical trial sites widely accessible. There are centres in Trois-Rivières, Chicago and York among other locations."
Answered by AI
Are people still being accepted into this scientific investigation?
"This trial is still recruiting patients, according to the information available on clinicaltrials.gov. The listing for this trial was first posted on June 30th, 2021 and last updated on November 17th, 2022."
Answered by AI
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