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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03357731
Other study ID # CV013-020
Secondary ID 2016-003586-26
Status Completed
Phase Phase 2
First received
Last updated
Start date November 30, 2017
Est. completion date May 10, 2019

Study information

Verified date July 2020
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date May 10, 2019
Est. primary completion date May 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 ß 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HNO Donor
Infusion
Nitroglycerin (NTG)
Infusion
Other:
Placebo
Infusion

Locations

Country Name City State
Japan Local Institution Kawasaki Kanagawa
Japan Local Institution Nagoya Aichi
Japan Local Institution Suita-shi Osaka
Netherlands Local Institution Groiningen
United Kingdom Local Institution Edinburgh
United Kingdom Local Institution Glasgow
United Kingdom Local Institution Glasgow
United Kingdom Local Institution Glasgow
United Kingdom Local Institution Harrow
United Kingdom Local Institution London
United Kingdom Local Institution London
United Kingdom Local Institution London
United States Brigham and Womens Hospital Boston Massachusetts
United States Northwestern Medicine Chicago Illinois
United States Duke Advanced Heart and Lung Failure Clinic Durham North Carolina
United States Inova Heart and Vascular Institute Falls Church Virginia
United States Indiana University School of Medicine-Indianapolis Indianapolis Indiana
United States Orange County Research Center Tustin California

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Japan,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
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 The objective is to evaluate the effects of BMS-986231 on the left ventricular (LV) systolic function by stroke volume index (SVI) assessed by echocardiography compared to placebo. at the end of the 5-hour infusion
Secondary Mean SVI Derived From LVOT VTI at the End of the 5-hour Infusion of BMS-986231, Versus NTG The objective is to evaluate the effects of BMS-986231 on the left ventricular (LV) systolic function by stroke volume index (SVI) assessed by echocardiography compared to NTG. at the end of the 5-hour infusion
Secondary Mean LVEF, Computed by Simpson's Method at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG:
LV ejection fraction
at the end of the 5-hour infusion
Secondary Mean Cardiac Power Index at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG:
Mean LV power index
at the end of the 5-hour infusion
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 Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG:
Diastolic function
at the end of the 5-hour infusion
Secondary Mean Diastolic Indices: Annular e' Velocity at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG:
Diastolic function
at the end of the 5-hour infusion
Secondary Mean LV Global Longitudinal Strain, Computed Using STE at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG:
LV global longitudinal strain
at the end of the 5-hour infusion
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