HNO DONOR for Heart Failure and Impaired Systolic Function
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients with Heart Failure and Impaired Systolic Function
IRAS ID
221987
Contact name
Head of Global Clinical trial Submission Unit
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2016-001685-29
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
The Present study is a Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO DONOR in Hospitalised Patients with Heart Failure and Impaired Systolic Function.
The purpose of this study is to evaluate the safety and effectiveness of HNO DONOR in patients with acute heart failure when added to the standard treatment. Reduced strength of contraction means that the heart is not pumping a sufficient amount of blood out of the heart with each beat. ADHF (Acute decompensated heart function) is a common and potentially serious cause of troubled breathing, caused by the heart not pumping as strongly as it should.
HNO DONOR has been tested previously in about 126 humans. The results have shown decreases in pressures in the heart and increases in how well the heart works.
Participants will be randomly assigned, to either HNO DONOR or placebo, and will receive HNO DONOR in addition to standard treatment for ADHF. Participants in part 1 have 50% chance of receiving HNO DONOR or placebo. Participants in part 2 have 66.7% chance of receiving HNO DONOR and 33.3% chance of Placebo.
It is expected that about 310 patients will be in this study. 100 participants will be treated in Part 1 (Cohort I) and 210 participants will be treated in Part 2 (Cohort II).
The average length of stay for patients with ADHF is 7-9 days. The inpatient period of the study will end with the final assessments at Hour 120 (Day 5) or discharge, whichever comes first.
In both Part 1 and Part 2, the study drug will be given as a continuous 48-hour infusion during the hospital stay. The dose will be based on body weight.REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0027
Date of REC Opinion
21 Apr 2017
REC opinion
Further Information Favourable Opinion