Phase 2
N=45
A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function
Heart Failure · Cardiac Failure · Reduced Ventricular Ejection Fraction
Bottom Line
View on ClinicalTrials.gov: NCT03357731 ↗Enrolled (actual)
45
Serious AEs
1.6%
Results posted
Jul 2020
Primary outcome: Primary: Mean Stroke Volume Index (SVI) Derived From the Velocity Time Integral at the Left Ventricular Outflow Tract (LVOT VTI) at the End of the 5-hour Infusion of BMS-986231, Versus Placebo — 29.545; 28.721 mL/m^2 — p=0.027
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HNO Donor (Drug); Nitroglycerin (NTG) (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Stroke Volume Index (SVI) Derived From the Velocity Time Integral at the Left Ventricular Outflow Tract (LVOT VTI) at the End of the 5-hour Infusion of BMS-986231, Versus Placebo |
29.545; 28.721 | 0.027 sig |
| SECONDARY Mean SVI Derived From LVOT VTI at the End of the 5-hour Infusion of BMS-986231, Versus NTG |
28.721; 27.811 | 0.846 |
| SECONDARY Mean LVEF, Computed by Simpson's Method at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG |
31.9; 32.8; 33.5 | 0.177 |
| SECONDARY Mean Cardiac Power Index at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG |
0.4122; 0.3427; 0.3568 | 0.007 sig |
| SECONDARY Mean Diastolic Indices: E/A and E/e' Ratio at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG |
0.80; 0.73; 0.71; 9.42; 7.00; 7.81 | 0.003 sig |
| SECONDARY Mean Diastolic Indices: Annular e' Velocity at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG |
7.18; 8.07; 7.18 | 0.994 |
| SECONDARY Mean LV Global Longitudinal Strain, Computed Using STE at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG |
-11.98; -11.94; -11.36 | 0.705 |
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.
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Heart failure with reduced ejection fraction (LVEF on echocardiogram of 40% or less)
- Stable guideline directed therapy for heart failure including oral diuretics, ACEi, ARBs, ARNi, MRAs, and β blockers as tolerated, with no dose changes of these medications in the past 2 weeks
- Have screening values of NT pro-BNP ≥ 125 pg/mL (15 pmol/L) or BNP ≥ 35 pg/mL (10 pmol/L)
Exclusion Criteria
- Systolic blood pressure (SBP) 90 bpm at screening or pre-randomization
- Permanent Atrial Fibrillation, Atrial Flutter or having Atrial Fibrillation, Atrial Flutter
- Estimated glomerular filtration rate (eGFR) < 15 ml/min/1.73 m2
- Ventricular assist device or prior heart transplant
- Prior solid organ transplant
- Body weight < 45 kg or ≥ 140 kg
- Low quality echocardiographic visualization windows and image acquisition
- Permanent paced rhythm (VVI, DDD or BiV pacing)
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT03357731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.