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Study of the Safety of BMS-986259 in Participants With Post-acute Decompensated Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318093
Recruitment Status : Not yet recruiting
First Posted : March 23, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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)
Estimated Enrollment : 72 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
Estimated Study Start Date : July 21, 2020
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: BMS-986259 Drug: BMS-986259
Specified dose on specified days

Placebo Comparator: Placebo Other: Placebo
Specified dose on specified days




Primary Outcome Measures :
  1. Incidence of clinically relevant hypotension [ Time Frame: Up to 14 days ]

Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: On day 5 ]
  2. Time of maximum observed plasma concentration (Tmax) [ Time Frame: On day 5 ]
  3. Area under the concentration-time curve in one dosing interval [AUC(TAU)] [ Time Frame: On day 5 ]
  4. Concentration at 24 hours post-dose (C24) [ Time Frame: On day 5 ]
  5. Incidence of Non-Serious Adverse Events [ Time Frame: Up to 32 days ]
  6. Incidence of Serious Adverse Events [ Time Frame: Up to 70 days and up to 3 months for participants who develop Anti-Drug Antibody (ADA) ]
  7. Incidence of clinically significant changes in vital signs of body temperature [ Time Frame: Up to 22 days ]
  8. Incidence of clinically significant changes in vital signs of respiratory rate [ Time Frame: Up to 22 days ]
  9. Incidence of clinically significant changes in vital signs of blood pressure [ Time Frame: Up to 22 days ]
  10. Incidence of clinically significant changes in vital signs of heart rate [ Time Frame: Up to 22 days ]
  11. Incidence of clinically significant changes in clinical laboratory tests of clinical chemistry [ Time Frame: Up to 40 days ]
  12. Incidence of clinically significant changes in clinical laboratory tests of hematology [ Time Frame: Up to 40 days ]
  13. Incidence of clinically significant changes in clinical laboratory tests of urinalysis [ Time Frame: Up to 40 days ]
  14. Incidence of clinically significant changes in electrocardiogram (ECG) parameters [ Time Frame: Up to 22 days ]
  15. Incidence of clinically significant changes from baseline in physical examination findings [ Time Frame: Up to 22 days ]


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.


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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:

  • Patients currently hospitalized for acute decompensated heart failure (ADHF)
  • Patients 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


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


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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Argentina
Local Institution
Córdoba, Cordoba, Argentina, X5000AAX
Contact: Site 0007         
Local Institution
Córdoba, Cordoba, Argentina, X5000
Contact: Site 0028         
Local Institution
Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina, C1093AAS
Contact: Site 0008         
Local Institution
Buenos Aires, Argentina, 1128
Contact: Site 0009         
Local Institution
Cordoba, Argentina, 5000
Contact: Site 0010         
Local Institution
Cordoba, Argentina, X50061KK
Contact: Site 0025         
Netherlands
Local Institution
Groningen, Netherlands, 9700
Contact: Site 0016         
Poland
Local Institution
Wroclaw, Poland, 50-556
Contact: Site 0030         
Local Institution
Wroclaw, Poland, 54-049
Contact: Site 0027         
United Kingdom
Local Institution
Edinburgh, United Kingdom, EH16 4SA
Contact: Site 0017         
Local Institution
Swindon, United Kingdom, SN3 6BB
Contact: Site 0019         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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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
Last Update Posted: May 12, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Bristol-Myers Squibb:
Heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases