NCT03357731|CompletedPhase 2ResultsFDA Drug

A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function

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

Bristol-Myers Squibb ClinicalTrials.gov

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2 other identifiers

CV013-0202016-003586-26

Study Type

interventional

Target

Locations

4 countries

Sites

Timeline

RegisteredNov 2017

StartedNov 2017

CompletionMay 2019

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2 heart-failure

Timeline

Completed

Started Nov 2017

Geographic Reach

4 countries

18 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

First Submitted

Initial submission to the registry

October 31, 2017

Completed

1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed

Same day until next milestone

Study Start

First participant enrolled

November 30, 2017

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2019

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

July 27, 2020

Completed

Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

October 31, 2017

Results QC Date

May 6, 2020

Last Update Submit

July 24, 2020

Conditions

Heart Failure Cardiac Failure Reduced Ventricular Ejection Fraction

Outcome Measures

Primary Outcomes (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
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 Outcomes (6)

Mean SVI Derived From LVOT VTI at the End of the 5-hour Infusion of BMS-986231, Versus NTG
at the end of the 5-hour infusion
Mean LVEF, Computed by Simpson's Method at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG
at the end of the 5-hour infusion
Mean Cardiac Power Index at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG
at the end of the 5-hour infusion
Mean Diastolic Indices: E/A and E/e' Ratio at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG
at the end of the 5-hour infusion
Mean Diastolic Indices: Annular e' Velocity at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG
at the end of the 5-hour infusion
+1 more secondary outcomes