Continuous 5-hour IV Infusions of BMS-986231 in Heart Failure Patients
Research type
Research Study
Full title
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
IRAS ID
230812
Contact name
Ninian Lang
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2016-003586-26
Duration of Study in the UK
1 years, 1 months, 30 days
Research summary
Heart failure is a long-term illness where the heart has been damaged and does not pump blood through the body well. BMS-986231 is being developed to treat patients hospitalised with heart failure. Results from previous studies with BMS-986231 have shown decreases in the pressures in the heart and increases in how well the heart works.
The purpose of this study is to evaluate the safety and effect of BMS-986231 on the heart’s ability to pump and fill with blood in adults with heart failure.
42 patients will participate in this study, which will consist of a screening period and 3 different treatment periods. During each treatment period the patient will receive by intravenous infusion one of three study interventions: BMS-986231, nitroglycerin, or placebo.During screening, patients will undergo various procedures and will be assessed for eligibility. Each eligible patient will receive the 3 interventions in random order. Participants or study staff will not know which intervention they are assigned to receive.
Each study treatment will be administered as a 5-hour infusion and the patient will remain in the clinic for 3.5 hours after the infusion. Each treatment period is followed by a wash-out period of a minimum of 7 days, and a maximum of 28 days. Study staff will contact participants by phone the day after each infusion and 30 days after the final infusion.
Participants will be asked to visit the clinic at least 4 times during the course of the study, over a maximum duration of 142 days. Study procedures include physical examinations, vital signs, ECGs, blood and urine tests, and non-invasive tests of cardiac function.
Bristol-Myers Squibb is the Sponsor.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0341
Date of REC Opinion
3 Oct 2017
REC opinion
Further Information Favourable Opinion