At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 49 enrolled
Drug / intervention
HNO Donor +2 moredrug
Likely dose
BMS-986231 as continuous 5-hour intravenous infusionAI-extracted
Key inclusion· 3
- ✓Heart failure with reduced ejection fraction (LVEF ≤40%)
- ✓Stable guideline-directed therapy for heart failure (ACEi, ARBs, ARNi, MRAs, β-blockers, diuretics) with no dose changes in past 2 weeks
- ✓Elevated natriuretic peptides: NT pro-BNP ≥125 pg/mL or BNP ≥35 pg/mL
Key exclusion· 8
- ✕Systolic blood pressure <110 mmHg at screening or pre-randomization
- ✕Heart rate <50 bpm or >90 bpm at screening or pre-randomization
- ✕Permanent atrial fibrillation or atrial flutter
- ✕eGFR <15 mL/min/1.73 m²
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Cross-over Phase 2 Study of Continuous 5-Hour Intravenous Infusions of BMS-986231 in Patients With Heart Failure and Impaired Systolic Function
In Brief
A Phase 2 clinical trial evaluating HNO Donor, Nitroglycerin (NTG), and 1 other intervention for Heart Failure and 2 related conditions. Completed, enrolled 49 participants across 18 sites in 4 countries.
Detailed Summary
The purpose of this study is to evaluate the effects of BMS-986231 on systolic and diastolic parameters in patients with heart failure and low ejection fraction.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan, Netherlands, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartNov 2017
Primary CompletionMay 2019
TodayJul 2026
First PostedNov 30, 2017
Enrollment StartNov 30, 2017
Primary CompletionMay 10, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.6 years ago
Interventions
HNO Donordrug
Infusion
Nitroglycerin (NTG)drug
Infusion
Placeboother
Infusion