← Back to Search

Monoclonal Antibodies

BMS-986435 for Heart Failure (AURORA-HFpEF Trial)

Phase 2
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 15 weeks
Awards & highlights

AURORA-HFpEF Trial Summary

This trial will study a drug to see if it's safe & effective in treating heart failure with preserved ejection fraction.

Who is the study for?
This trial is for adults with stable, symptomatic heart failure but whose hearts can still pump normally (HFpEF). People with obstructive or genetic heart muscle issues, storage disorders like cardiac amyloidosis, or any serious condition that could affect the study or be risky can't join.Check my eligibility
What is being tested?
The study tests BMS-986435/MYK-224's safety and how well it's tolerated in people with HFpEF. It also looks at how drug levels relate to its effects. Participants will either receive this new drug or a placebo for comparison.See study design
What are the potential side effects?
While specific side effects of BMS-986435/MYK-224 are not listed here, common ones may include reactions at the injection site, nausea, fatigue, dizziness and potential impact on kidney function.

AURORA-HFpEF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have stable heart failure with preserved ejection fraction.

AURORA-HFpEF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 15 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 15 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of AEs leading to treatment discontinuation
Incidence of serious adverse events (SAEs)
Incidence of treatment emergent adverse events (TEAEs)
Secondary outcome measures
Summary of plasma concentrations of MYK-224

AURORA-HFpEF Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BMS-986435Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,641 Previous Clinical Trials
4,130,016 Total Patients Enrolled
28 Trials studying Heart Failure
169,258 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted authorization for BMS-986435?

"Despite the lack of evidence regarding BMS-986435's efficacy, prior clinical data provides assurance on its safety. This is reflected in a score of 2."

Answered by AI

Who meets the qualifications to join this medical experiment?

"To meet the entry requirements of this trial, prospective participants must possess a diagnosis of heart failure and be between 40-90 years old. Currently, 48 volunteers are required for enrolment."

Answered by AI

Is this research actively enlisting participants?

"Affirmative. According to the information compiled on clinicaltrials.gov, this research effort is currently recruiting patients and was first posted on November 7th 2023 with a recent update occurring on November 17th 2023. At present, it seeks 48 participants across 38 sites."

Answered by AI

Does the protocol for this experiment include geriatric participants?

"The required age range for this clinical study is between 40 and 90 years old. In comparison, there are 27 trials that recruit minors (under 18) and 774 studies recruiting seniors above the age of 65."

Answered by AI

Are there various locations in the city that are carrying out this clinical trial?

"At present, 38 medical sites are accepting participants for the trial. These locations span cities such as Massa, Saint Louis and Houston; thus it is recommended to choose a centre closest to your residence in order to lower any travelling costs if you decide to take part."

Answered by AI

What is the magnitude of participants in this medical experiment?

"In order to successfully complete this medical trial, 48 candidates that meet the designated inclusion criteria are needed. Participants may join from Local Institution - 0052 in Massa, Toscana or St. Louis Heart and Vascular in Saint Louis, Missouri."

Answered by AI

Who else is applying?

What site did they apply to?
University of Texas Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
2023. "Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06122779.
All > Nashville
~27 spots leftby Jan 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