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Brief Summary:
The purpose of the study is to assess the safety of BMS-986259 in stable participants hospitalized for acute decompensated heart failure.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Decompensated Heart Failure | Drug: BMS-986259 Other: Placebo | Phase 2 |
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| Study Type : | Interventional (Clinical Trial) |
| ActualEnrollment : | 25 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | November 6, 2020 |
| Actual Primary Completion Date : | July 19, 2021 |
| Actual Study Completion Date : | July 19, 2021 |
Resource links provided by the National Library of Medicine 
MedlinePlus related topics: HeartFailure
U.S. FDA Resources
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| Arm | Intervention/treatment |
|---|---|
| Experimental: BMS-986259 | Drug: BMS-986259 Specified dose on specified days |
| Placebo Comparator: Placebo | Other: Placebo Specified dose on specified days |
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Primary Outcome Measures :
- Percentage of Participants Experiencing Clinically Relevant Hypotension [TimeFrame: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).
Secondary Outcome Measures :
- Maximum Observed Serum Concentration (Cmax) [TimeFrame:Day 1 and Day 5 of study treatment]
- Time of Maximum Observed Serum Concentration (Tmax) [TimeFrame:Day 1 and Day 5 of study treatment]
- Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU)) [TimeFrame:Day 1 and Day 5 of study treatment]
- Trough Concentration (Ctrough) [TimeFrame:Day 2 through Day 14 of study treatment (with the exception of Day 11, for which data is not available)]
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318093
Locations
| Argentina | |
| Local Institution - 0009 | |
| Ciudad de Buenos Aires, Buenos Aires, Argentina, 1180 | |
| Local Institution - 0007 | |
| Alberdi, Cordoba, Argentina, 5000 | |
| Local Institution - 0010 | |
| Córdoba, Cordoba, Argentina, X5000EPU | |
| Local Institution | |
| Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina, C1093AAS | |
| Local Institution - 0028 | |
| Cordoba, Provincia DE Cordoba, Argentina, 5000 | |
| Local Institution - 0025 | |
| Cordoba, Argentina, 5006 | |
| Czechia | |
| Local Institution - 0020 | |
| Praha 2, Czechia, 12808 | |
| Nemocnice Slany-Interna - kardiologicka ambulance | |
| Slany, Czechia, 274 01 | |
| Greece | |
| Local Institution - 0011 | |
| Athens, Greece, 11527 | |
| Local Institution - 0022 | |
| Athens, Greece, 142 33 | |
| Israel | |
| Local Institution - 0014 | |
| Tel Aviv, Tell Abīb, Israel, 6423906 | |
| Local Institution | |
| Jerusalem, Israel, 912001 | |
| Local Institution | |
| Petah Tikva, Israel, 4941492 | |
| Poland | |
| Local Institution - 0034 | |
| Bialystok, Poland, 15 276 | |
| Local Institution - 0030 | |
| Wrocaw, Poland, 50-556 | |
| Local Institution - 0027 | |
| Wroclaw, Poland, 54-049 | |
| United Kingdom | |
| Local Institution | |
| Edinburgh, United Kingdom, EH16 4SA | |
| Local Institution | |
| Swindon, United Kingdom, SN3 6BB | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Study Documents (Full-Text)
Documents provided by Bristol-Myers Squibb:
Study Protocol and Statistical Analysis Plan [PDF] October 28, 2020
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Additional Information:
BMS Clinical Trial Information 
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Investigator Inquiry Form
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT04318093 |
| Other Study ID Numbers: | CV019-010 2019-004186-40 ( EudraCT Number ) |
| First Posted: | March 23, 2020 Key Record Dates |
| Results First Posted: | August 4, 2022 |
| Last Update Posted: | August 4, 2022 |
| Last Verified: | August 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Bristol-Myers Squibb:
| Heart failure |
Additional relevant MeSH terms:
| Heart Failure Heart Diseases Cardiovascular Diseases |
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