Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure
Primary Purpose
Acute Decompensated Heart Failure
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-986259
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Decompensated Heart Failure focused on measuring Heart failure
Eligibility 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
Sites / Locations
- Local Institution - 0009
- Local Institution - 0007
- Local Institution - 0010
- Local Institution
- Local Institution - 0028
- Local Institution - 0025
- Local Institution - 0020
- Nemocnice Slany-Interna - kardiologicka ambulance
- Local Institution - 0011
- Local Institution - 0022
- Local Institution - 0014
- Local Institution
- Local Institution
- Local Institution - 0034
- Local Institution - 0030
- Local Institution - 0027
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BMS-986259
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Maximum Observed Serum Concentration (Cmax)
Time of Maximum Observed Serum Concentration (Tmax)
Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU))
Trough Concentration (Ctrough)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04318093
Brief Title
Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 6, 2020 (Actual)
Primary Completion Date
July 19, 2021 (Actual)
Study Completion Date
July 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to assess the safety of BMS-986259 in stable participants hospitalized for acute decompensated heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure
Keywords
Heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS-986259
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-986259
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Percentage of Participants Experiencing Clinically Relevant Hypotension
Description
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).
Time Frame
From first dose to 30 days following first dose
Secondary Outcome Measure Information:
Title
Maximum Observed Serum Concentration (Cmax)
Time Frame
Day 1 and Day 5 of study treatment
Title
Time of Maximum Observed Serum Concentration (Tmax)
Time Frame
Day 1 and Day 5 of study treatment
Title
Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU))
Time Frame
Day 1 and Day 5 of study treatment
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0009
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1180
Country
Argentina
Facility Name
Local Institution - 0007
City
Alberdi
State/Province
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution - 0010
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
X5000EPU
Country
Argentina
Facility Name
Local Institution
City
Ciudad Autónoma de Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Local Institution - 0028
City
Cordoba
State/Province
Provincia DE Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution - 0025
City
Cordoba
ZIP/Postal Code
5006
Country
Argentina
Facility Name
Local Institution - 0020
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Nemocnice Slany-Interna - kardiologicka ambulance
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
Local Institution - 0011
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Local Institution - 0022
City
Athens
ZIP/Postal Code
142 33
Country
Greece
Facility Name
Local Institution - 0014
City
Tel Aviv
State/Province
Tell Abīb
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
912001
Country
Israel
Facility Name
Local Institution
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Local Institution - 0034
City
Bialystok
ZIP/Postal Code
15 276
Country
Poland
Facility Name
Local Institution - 0030
City
Wrocaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Local Institution - 0027
City
Wroclaw
ZIP/Postal Code
54-049
Country
Poland
Facility Name
Local Institution
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Local Institution
City
Swindon
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
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Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure
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