A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impair… (NCT03357731) | Clinical Trial Compass
CompletedPhase 2
A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function
United States49 participantsStarted 2017-11-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) \< 110 mm Hg at screening or pre-randomization
* Heart rate \< 50 beats per minute (bpm) or \> 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
What they're measuring
1
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