NCT04318093

Brief Summary

The purpose of the study is to assess the safety of BMS-986259 in stable participants hospitalized for acute decompensated heart failure.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2020

Shorter than P25 for phase_2

Geographic Reach
6 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

November 6, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2021

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 4, 2022

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

9 months

First QC Date

March 20, 2020

Results QC Date

July 6, 2022

Last Update Submit

August 3, 2022

Conditions

Acute Decompensated Heart Failure

Keywords

Heart failure

Outcome Measures

Primary Outcomes (1)

  • 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).

    From first dose to 30 days following first dose

Secondary Outcomes (4)

  • Maximum Observed Serum Concentration (Cmax)

    Day 1 and Day 5 of study treatment

  • Time of Maximum Observed Serum Concentration (Tmax)

    Day 1 and Day 5 of study treatment

  • Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU))

    Day 1 and Day 5 of study treatment

  • Trough Concentration (Ctrough)

    Day 2 through Day 14 of study treatment (with the exception of Day 11, for which data is not available)

Study Arms (2)

BMS-986259

EXPERIMENTAL
Drug: BMS-986259

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

BMS-986259DRUG

Specified dose on specified days

BMS-986259
PlaceboOTHER

Specified dose on specified days

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Local Institution - 0009

Ciudad de Buenos Aires, Buenos Aires, 1180, Argentina

Location

Local Institution - 0007

Alberdi, Córdoba Province, 5000, Argentina

Location

Local Institution - 0028

Córdoba, Córdoba Province, 5000, Argentina

Location

Local Institution - 0010

Córdoba, Córdoba Province, X5000EPU, Argentina

Location

Local Institution

Buenos Aires, Distrito Federal, C1093AAS, Argentina

Location

Local Institution - 0025

Córdoba, 5006, Argentina

Location

Local Institution - 0020

Prague, 12808, Czechia

Location

Nemocnice Slany-Interna - kardiologicka ambulance

Slaný, 274 01, Czechia

Location

Local Institution - 0011

Athens, 11527, Greece

Location

Local Institution - 0022

Athens, 142 33, Greece

Location

Local Institution - 0014

Tel Aviv, Tell Abīb, 6423906, Israel

Location

Local Institution

Jerusalem, 912001, Israel

Location

Local Institution

Petah Tikva, 4941492, Israel

Location

Local Institution - 0034

Bialystok, 15 276, Poland

Location

Local Institution - 0030

Wrocaw, 50-556, Poland

Location

Local Institution - 0027

Wroclaw, 54-049, Poland

Location

Local Institution

Edinburgh, EH16 4SA, United Kingdom

Location

Local Institution

Swindon, SN3 6BB, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com
Please email

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2020

First Posted

March 23, 2020

Study Start

November 6, 2020

Primary Completion

July 19, 2021

Study Completion

July 19, 2021

Last Updated

August 4, 2022

Results First Posted

August 4, 2022

Record last verified: 2022-08

Locations

IL(3)GR(2)AR(6)PL(3)CZ(2)GB(2)