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Danicamtiv's Effect on Midazolam for Heart Failure

Phase 1
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ambulatory participants with stable HFrEF due to any etiology
Body mass index (BMI) of 18.0 kg/m2 to 35.0 kg/m2 inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 12
Awards & highlights

Study Summary

This trial is testing if a drug (danicamtiv) can increase the levels of another drug (midazolam) in people with HFrEF.

Who is the study for?
This trial is for adults with stable heart failure and a BMI of 18-35. They must have a documented left ventricular ejection fraction between 15% to 45%, be on stable heart failure medication, and have either sinus rhythm or controlled atrial fibrillation. People with severe allergies to the drugs being tested, severe kidney issues, or certain irregular heart rhythms cannot participate.Check my eligibility
What is being tested?
The study is testing how danicamtiv affects the levels of another drug called midazolam in patients with reduced heart function (HFrEF). Participants will receive danicamtiv to see if it changes how midazolam works in their bodies.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include reactions related to typical heart medications and those specific to danicamtiv or midazolam such as drowsiness, respiratory issues, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk and have stable heart failure with reduced ejection fraction.
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My BMI is between 18.0 and 35.0.
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My heart's pumping ability is reduced but stable, as shown in recent tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC[INF])
Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Maximum observed plasma concentration (Cmax)
Secondary outcome measures
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Number of participants with clinical laboratory abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Danicamtiv + MidazolamExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Danicamtiv
2023
Completed Phase 1
~70
Midazolam
2018
Completed Phase 4
~1910

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,501 Total Patients Enrolled
28 Trials studying Heart Failure
169,293 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.

Does the program accept participants under 85 years of age?

"This medical research has established 18 years old as the lower age limit and 75 years old as the upper threshold for participation."

Answered by AI

Are there any recruitment opportunities for volunteers to join this research?

"As per the information available on clinicaltrials.gov, this scientific experiment is actively looking for volunteers to participate. It was initially posted in 17th August 2023 and its most recent update took place 8th September of that year."

Answered by AI

Am I qualified to enroll in this trial?

"This research trial requires that applicants possess a diagnosis of heart failure and are between 18-75 years old. At the moment, 16 participants must be identified to reach their recruitment goal."

Answered by AI

What hazards are associated with the Danicamtiv + Midazolam combination?

"As a Phase 1 trial, the safety of Danicamtiv + Midazolam has limited data to support its efficacy and so our team at Power have marked it with score of 1."

Answered by AI

In what areas can participants access this research?

"At this time, there are 4 clinical trial sites recruiting: Jacksonville, Owensboro, Baltimore and four additional cities. If you wish to participate in the study it is recommended that you select a location closest to your home for reduced travel requirements."

Answered by AI

How many participants can take part in this research project?

"This clinical trial necessitates 16 participants that are eligible based on the inclusion criteria. Individuals can engage in this investigation at either Jacksonville Center For Clinical Research or Research Integrity LLC, both of which have locations in Jacksonville and Owensboro respectively."

Answered by AI

Who else is applying?

What site did they apply to?
Sinai Hospital Of Baltimore
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Effect of Danicamtiv on the Drug Levels of Midazolam in Participants With Stable Heart Failure
2023. "A Study to Assess the Effect of Danicamtiv on the Drug Levels of Midazolam in Participants With Stable Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05952089.
~8 spots leftby Apr 2025
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