TRANSITION_LCZ696 pre/ post discharge in acute heart failure
Research type
Research Study
Full title
A multicenter, randomized, open label, parallel group study comparing pre-discharge and posT-discharge tReatment initiation with LCZ696 in heArt failure patieNtS with reduced ejectIon-fracTion hospItalized for an acute decOmpensation eveNt (ADHF) (the TRANSITION study)
IRAS ID
190077
Contact name
Klaus Witte
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2015-003266-87
Clinicaltrials.gov Identifier
CARD 4353, Research Network
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
Heart failure (HF) occurs when the heart muscle doesn’t pump blood as well as it should to meet the body’s needs for blood and oxygen. Acute decompensated HF is a rapid decline in the signs and symptoms of HF (commonly shortness of breath, swelling, fatigue), requiring emergency admission to hospital. HF is a major and increasingly prevalent condition affecting >550,000 people in the UK, with an estimated 68,000 new cases annually. In spite of improvements in outcomes over the last 20 years, morbidity and mortality remain high and there is a need for better treatments in order to improve outcomes. Overall, 50% of patients die within 4 years and 40% of patients admitted to the hospital with HF die or are readmitted within 1 year. Thus, HF still represents a major cause of cardiac mortality and morbidity with a clear need for better medicines. Drugs of the angiotensin converting enzyme inhibitor (known as ACE Inhibitors) and angiotensin receptor blockers (known as ARBs) and beta blocker groups of medicines have formed the main support of the treatment of heart failure.
LCZ696 is a member of a new class of medicine called 'angiotensin receptor neprilysin inhibitors'. It has shown to be effective in heart failure as seen in the PARADIGM_HF study which investigated the use of LCZ696 given to chronic HF patients and was terminated early due to finding clear superiority of LCZ696 both from reduced mortality and hospitalisations compared to an ACE Inhibitor enalapril.
The purpose of this trial is to explore two new different timings for starting, LCZ696, in patients with Heart Failure once they have been stabilized after an acute decompensated heart failure (ADHF) episode. The trial will compare ADHF patients starting LCZ696 before discharge from hospital and those starting LCZ696 after discharge from hospital.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
15/YH/0535
Date of REC Opinion
18 Dec 2015
REC opinion
Further Information Favourable Opinion