14836 'COMPOSE EARLY' - Cinaciguat in ADHF
Research type
Research Study
Full title
A Placebo Controlled, Randomised, Double-Blind, Fixed-dose, Multicentre, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (150 ug/h, 100 ug/h, 50 ug/h) Given Intravenously to Subjectes with Acute Decompensated Chronic Congestive Heart Failure (ADHF) within 12 hours after hospital admission (Pulmonary Artery Catheter e.g. Swan-Ganz not required)
IRAS ID
37422
Contact name
C Justin Cooke
Sponsor organisation
Bayer HealthCare AG c/o Bayer plc
Eudract number
2009-017082-39
Clinicaltrials.gov Identifier
Research summary
Heart failure is the leading cause of hospitalisation in patients aged over 65 years. It is a major health problem accounting for significant health care expenditure. During ADHF hospitalisations, initial treatment priorities relate to symptom management. Current approved ADHF treatments are limited and have significant side-effects.This study investigates safety and effectiveness of the study drug (??Cinaciguat??); a new medicine which may offer therapeutic advantages. Cinaciguat will be given at fixed doses in ADHF subjects requiring drug therapy, who can commence treatment within 12 hours of admission.The study will evaluate the subject??s well-being by scores from questionnaires about breathing difficulty.The effect of Cinaciguat will be studied in 160 patients globally, in approximately 60 centres, with 2 in the UK. Subjects will be randomly computer-assigned to receive either one of three different doses of Cinaciguat, or a placebo treatment for 24-48 hours given via a needle into a blood vessel. Subjects have an equal chance of being placed in any of the four treatment groups. All subjects will also receive usual standard of care at the study centre for this illness in addition to their study treatment. Allocation to the placebo group will not deny patients a treatment they would otherwise receive. Nitrates, routinely used in some centres, are excluded in this study.Subjects will have regular heart tracings (ECGs) and study doctor checks to ensure well-being throughout the study, including regular blood pressure and heart rate checks. Blood and urine samples will be taken for study-specific and safety tests. Patients will be asked to complete simple questionnaires about their well-being at several timepoints during and after study treatment.By participating it is hoped that patients will benefit from improved well-being. Important information about the safety and effectiveness of Cinaciguat will hopefully be gained, potentially benefiting future patients.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
10/H1307/94
Date of REC Opinion
1 Sep 2010
REC opinion
Further Information Favourable Opinion