Clinical trial NCT04318093: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Decompensated Heart Failure
Keywords: Heart failure
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-03-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the safety of BMS-986259 in stable participants hospitalized for acute decompensated 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

Primary outcomes:
measure: Percentage of Participants Experiencing Clinically Relevant Hypotension
timeFrame: From first dose to 30 days following first dose
Secondary outcomes:
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: Day 1 and Day 5 of study treatment
measure: Time of Maximum Observed Serum Concentration (Tmax)
timeFrame: Day 1 and Day 5 of study treatment
measure: Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU))
timeFrame: Day 1 and Day 5 of study treatment
measure: Trough Concentration (Ctrough)
timeFrame: Day 2 through Day 14 of study treatment (with the exception of Day 11, for which data is not available)
Other outcomes:
Locations:
city: Ciudad de Buenos Aires
country: Argentina
facility: Local Institution - 0009
state: Buenos Aires
city: Alberdi
country: Argentina
facility: Local Institution - 0007
state: Cordoba
city: Córdoba
country: Argentina
facility: Local Institution - 0010
state: Cordoba
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution
state: Distrito Federal
city: Cordoba
country: Argentina
facility: Local Institution - 0028
state: Provincia DE Cordoba
city: Cordoba
country: Argentina
facility: Local Institution - 0025
city: Praha 2
country: Czechia
facility: Local Institution - 0020
city: Slany
country: Czechia
facility: Nemocnice Slany-Interna - kardiologicka ambulance
city: Athens
country: Greece
facility: Local Institution - 0011
city: Athens
country: Greece
facility: Local Institution - 0022
city: Tel Aviv
country: Israel
facility: Local Institution - 0014
state: Tell Abīb
city: Jerusalem
country: Israel
facility: Local Institution
city: Petah Tikva
country: Israel
facility: Local Institution
city: Bialystok
country: Poland
facility: Local Institution - 0034
city: Wrocaw
country: Poland
facility: Local Institution - 0030
city: Wroclaw
country: Poland
facility: Local Institution - 0027
city: Edinburgh
country: United Kingdom
facility: Local Institution
city: Swindon
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: