BMS-986231 in Patients with HF and Impaired Systolic Function
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Cross-over Phase 2 Study of Continuous 8 Hour Intravenous Infusions of BMS-986231 in Patients with Heart Failure and Impaired Systolic Function Given a Standard Dose of Loop Diuretic
IRAS ID
245536
Contact name
Pierpaolo Pellicori
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2018-000970-31
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
When the heart becomes unable to pump enough blood around the body, it usually causes symptoms, such as breathlessness: this condition is called heart failure (HF). A failing heart sends signals to the kidneys, that start to retain salt and water; thus, patients with HF usually build up an excess of fluids. As a consequence, water tablets (diuretic) are often used to treat breathlessness and to remove an excessive amount of body fluid. However, complete fluid removal is not always successful.
Loop diuretics act on the kidney, and when kidneys do not work properly it might reduce diuretic efficacy. Importantly, many patients with HF also have impaired renal function. Study medication (BMS-986231) is being developed by Bristol-Myers Squib (BMS) to treat patients with HF. Results from previous BMS-986231 studies suggest that BMS-986231 improves the ability of the heart to pump or relax by widening the blood vessels, decreasing blood pressure, with the potential of reducing fluid retention in the body.
The purpose of this study is to evaluate the action of the investigational medicine, BMS-986231 on kidneys and their ability to eliminate salt and water alongside a loop diuretic.
This study is planned to involve 20 patients with long term, stable, HF. Participation will last up to 8 weeks and requires three (3) visits to the study site, including a screening visit and infusions with BMS-986231 or placebo in two separate occasions. This study is double-blinded, which means that neither the participants nor the study staff will know which intervention is administered to the patient in each occasion.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
18/NE/0257
Date of REC Opinion
18 Sep 2018
REC opinion
Further Information Favourable Opinion