LCZ696 in patients from Paradigm HF study
Research type
Research Study
Full title
A multicenter study to evaluate safety and tolerability in patients with chronic heart failure and reduced ejection fraction from PARADIGM-HF receiving open label LCZ696
IRAS ID
166568
Contact name
Cristina Serra
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2014-001971-30
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
Chronic Heart Failure (CHF) is a major public health problem. In the UK, around 900,000 people have CHF. Medical therapies for CHF have been well studied over the past two decades, leading to improved survival and reduced re-hospitalization for heart failure. However, despite these advances the outlook remains poor. 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 therapy.
This study is an open-label study enrolling eligible patients who previously completed the PARADIGM-HF (NCT01035255). The purpose is to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients. PARADIGM-HF was terminated early by the Data and Safety Monitoring Committee due to finding clear superiority (all-cause mortality, cardiovascular mortality, heart failure hospitalisation) of LCZ696 compared to enalapril 10mg B.D. At the end of the study, due to non-availability of LCZ for open label use, patients were prescribed an ACE inhibitor, in the majority of cases enalapril. This study will allow patients previously enrolled in PARADIGM-HF to be offered LCZ696 with concurrent collation of longer term safety information.
The study will last for up to 30 months (until the drug product becomes commercially available). Participants will be required to take the investigational medicine and attend up to 9 study visits.
The assessment of safety will be based primarily on the frequency of adverse events of special interest reported (angioedema, AEs suspected to be related to LCZ696, AEs leading to study drug discontinuation and serious adverse events (SAE) including death), sitting systolic and diastolic blood pressure, heart rate, and SAEs suspected by the investigators to be related to LCZ696.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/1267
Date of REC Opinion
16 Mar 2015
REC opinion
Further Information Favourable Opinion