Status:
COMPLETED
A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Heart Failure
Cardiac Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2019
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03357731
Start Date
November 30 2017
End Date
May 10 2019
Last Update
July 27 2020
Active Locations (18)
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1
Orange County Research Center
Tustin, California, United States, 92780
2
Northwestern Medicine
Chicago, Illinois, United States, 60611
3
Indiana University School of Medicine-Indianapolis
Indianapolis, Indiana, United States, 46202-1218
4
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115