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

Phase 2

Completed

• Conditions: Acute Decompensated Heart Failure
• Interventions: Other: Placebo; Drug: BMS-986259

• Registration Number: NCT04318093
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-23
• Study Start: 2020-11-06
• Primary Completion: 2021-07-19
• Study Completion: 2021-07-19
• Results First Submitted: 2022-07-06
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-03
• Last Update Submitted: 2022-08-03
• Results First Posted: 2022-08-04
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
BMS-986259	BMS-986259	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing Clinically Relevant Hypotension	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

Name	Time	Method
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
Trough Concentration (Ctrough)	Day 2 through Day 14 of study treatment (with the exception of Day 11, for which data is not available)
Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU))	Day 1 and Day 5 of study treatment

Trial Locations

Locations (14)

Local Institution - 0025; 🇦🇷 Cordoba, Argentina

Local Institution - 0009; 🇦🇷 Ciudad de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0022; 🇬🇷 Athens, Greece

Local Institution - 0007; 🇦🇷 Alberdi, Cordoba, Argentina

Local Institution; 🇬🇧 Swindon, United Kingdom

Local Institution - 0010; 🇦🇷 Córdoba, Cordoba, Argentina

Local Institution - 0028; 🇦🇷 Cordoba, Provincia DE Cordoba, Argentina

Local Institution - 0014; 🇮🇱 Tel Aviv, Tell Abīb, Israel

Local Institution - 0020; 🇨🇿 Praha 2, Czechia

Nemocnice Slany-Interna - kardiologicka ambulance; 🇨🇿 Slany, Czechia

Local Institution - 0011; 🇬🇷 Athens, Greece

Local Institution - 0034; 🇵🇱 Bialystok, Poland

Local Institution - 0030; 🇵🇱 Wrocaw, Poland

Local Institution - 0027; 🇵🇱 Wroclaw, Poland