Acute Decompensated Heart FailurePhase 2NCT04318093
Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure
A Phase 2 study testing BMS-986259 in people with Acute Decompensated Heart Failure, run by Bristol-Myers Squibb at 18 sites in 6 countries.
Trial summary
The purpose of the study is to assess the safety of BMS-986259 in stable participants hospitalized for acute decompensated heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- BMS-986259
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 6 Nov 2020to 19 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants currently hospitalized for acute decompensated heart failure (ADHF)
- Participants must be hemodynamically stable, as assessed by the investigator
- Men must agree to follow specific methods of contraception, if applicable, while participating in the trial
- Women participants must have documented proof that they are not of childbearing potential
Who cannot join
- Acute cardiovascular condition other than heart failure (HF) decompensation
- Cardiogenic shock at presentation to emergency room (ER) or at any time before randomization
- Recipient of ventricular assist devices or use of any cardiac extracorporeal devices, within 12 weeks of study randomization
- Participants with contraindications to vasodilator therapy such as restrictive or obstructive cardiomyopathy, severe mitral or aortic stenosis
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
Argentina6 sites
Local Institution - 0007
Alberdi, Córdoba Province, 5000
Local Institution
Buenos Aires, Distrito Federal, C1093AAS
Local Institution - 0009
Ciudad de Buenos Aires, Buenos Aires, 1180
Local Institution - 0028
Córdoba, Córdoba Province, 5000
Local Institution - 0010
Córdoba, Córdoba Province, X5000EPU
Local Institution - 0025
Córdoba, 5006
Israel3 sites
Local Institution
Jerusalem, 912001
Local Institution
Petah Tikva, 4941492
Local Institution - 0014
Tel Aviv, Tell Abīb, 6423906
Poland3 sites
Local Institution - 0034
Bialystok, 15 276
Local Institution - 0030
Wrocaw, 50-556
Local Institution - 0027
Wroclaw, 54-049
Czechia2 sites
Local Institution - 0020
Prague, 12808
Nemocnice Slany-Interna - kardiologicka ambulance
Slaný, 274 01
Greece2 sites
Local Institution - 0011
Athens, 11527
Local Institution - 0022
Athens, 142 33
United Kingdom2 sites
Local Institution
Edinburgh, EH16 4SA
Local Institution
Swindon, SN3 6BB
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of BMS-986259 in Stabilized Patients Hospitalized for Acute Decompensated Heart Failure
The purpose of the study is to assess the safety of BMS-986259 in stable participants hospitalized for acute decompensated heart failure.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- BMS-986259, Placebo
- Keywords
- Heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986259Drug
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986259 | Experimental | Not described Receives: Drug: BMS-986259 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Clinically Relevant Hypotension
Clinically Relevant Hypotension is defined as occurrence of any of the following:
- Supine Systolic Blood Pressure (SBP) <85 mmHg (confirmed by repeat measurement within 30 minutes), regardless of symptoms of hypotension
- Supine SBP <90 mmHg (confirmed by repeat measurement within 30 minutes) AND symptoms of hypotension (eg, dizziness, lightheadedness, etc).
Measured: From first dose to 30 days following first dose
Secondary outcomes (4)
Maximum Observed Serum Concentration (Cmax)
Measured: Day 1 and Day 5 of study treatment
Time of Maximum Observed Serum Concentration (Tmax)
Measured: Day 1 and Day 5 of study treatment
Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU))
Measured: Day 1 and Day 5 of study treatment
Trough Concentration (Ctrough)
Measured: Day 2 through Day 14 of study treatment (with the exception of Day 11, for which data is not available)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start6 Nov 2020
- Primary completion19 Jul 2021
- Study completion19 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318093
- Sponsor's protocol ID
- CV019-010
- Other IDs
- 2019-004186-40, 2019
- Status last verified
- Aug 2022
- First submitted
- 20 Mar 2020
- Last updated
- 4 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of BMS-986259 in Stabilized Patients Hospitalized for Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT04318093
- Acronym / sponsor ID
- CV019-010
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Heart failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 19 Jul 2021 (actual)
- First posted
- 23 Mar 2020 (actual)
- Results
- Posted 4 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the safety of BMS-986259 in stable participants hospitalized for acute decompensated heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMS-986259 | Experimental | Drug: BMS-986259 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants currently hospitalized for acute decompensated heart failure (ADHF)
- Participants must be hemodynamically stable, as assessed by the investigator
- Men must agree to follow specific methods of contraception, if applicable, while participating in the trial
- Women participants must have documented proof that they are not of childbearing potential
Key exclusion criteria (5 listed)
- Acute cardiovascular condition other than heart failure (HF) decompensation
- Cardiogenic shock at presentation to emergency room (ER) or at any time before randomization
- Recipient of ventricular assist devices or use of any cardiac extracorporeal devices, within 12 weeks of study randomization
- Participants with contraindications to vasodilator therapy such as restrictive or obstructive cardiomyopathy, severe mitral or aortic stenosis
- Other protocol-defined inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986259Specified dose on specified days | Drug | BMS-986259 |
| PlaceboSpecified dose on specified days | Other | Placebo |
Primary outcome
Percentage of Participants Experiencing Clinically Relevant Hypotension
Time frame: From first dose to 30 days following first dose
Clinically Relevant Hypotension is defined as occurrence of any of the following: * Supine Systolic Blood Pressure (SBP) <85 mmHg (confirmed by repeat measurement within 30 minutes), regardless of symptoms of hypotension * Supine SBP <90 mmHg (confirmed by repeat measurement within 30 minutes) AND symptoms of hypotension (eg, dizziness, lightheadedness, etc).
4 secondary outcomes
Maximum Observed Serum Concentration (Cmax)
Time frame: Day 1 and Day 5 of study treatment
Time of Maximum Observed Serum Concentration (Tmax)
Time frame: Day 1 and Day 5 of study treatment
Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU))
Time frame: Day 1 and Day 5 of study treatment
Trough Concentration (Ctrough)
Time frame: Day 2 through Day 14 of study treatment (with the exception of Day 11, for which data is not available)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
Related trials for Acute Decompensated Heart Failure
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
Acute Decompensated Heart Failure (ADHF)
Recruiting
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
Recruiting
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Acute Decompensated Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-986259 in people with Acute Decompensated Heart Failure, run by Bristol-Myers Squibb at 18 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Argentina, Israel, Poland, Czechia, Greece and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Clinically Relevant Hypotension (time frame: From first dose to 30 days following first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.