TITRATION - LCZ696 safety and tolerability in HFrEF patients
Research type
Research Study
Full title
A multicenter, randomized, double-blind, parallel group study to assess the safety and tolerability of initiating LCZ696 in heart failure patients comparing two titration regimens.
IRAS ID
142546
Contact name
Fosca De Iorio
Contact email
Sponsor organisation
Novartis Pharma services AG
Eudract number
2013-001835-33
Clinicaltrials.gov Identifier
Research summary
Heart failure is a major and increasingly prevalent condition affecting >900,000 people in the UK. In spite of improvements in outcomes over the last few decades, for heart failure with reduced pump function, the outcomes for the patient remain poor.
The aim of this study is to assess two different titration regiments of LCZ696 when started in either patients naïve to ACEI (angiotensin converting enzyme inhibitor) or ARB (angiotensin receptor blockers) treatment or those on stable doses of ACEI/ARB.
Eligible patients who consent to take part in the study will continue on their regular therapy for heart failure but any ARBs and ACEIs will be replaced by the study medication.
Safety and tolerability to the study drug will be assessed during the first 5 days during which patients will be receiving open label LCZ696 50 mg twice a day. After this period, patients who tolerate the study medication and meet the entry criteria will be randomly allocated to receive varying doses of LCZ696 as well as their usual treatment for chronic heart failure, in a double blind fashion. The allocated treatment will be ’double blind’ meaning that neither the doctor nor the patient will know which titration regimen patient was assigned to.
It is planned that patients will be in the study for up to 12 weeks, and will visit the clinic up to a total of 7 times over the whole study. 30 days after last dose of drug is administered, patients will be contacted by phone to obtain information about their safety. The main assessments during site visits will include physical examinations, blood pressure and pulse measurements, electrocardiograms as well as safety blood and urine tests.
Approximately 480 patients from across the world will be recruited into this study, of which approximately 30 will be from the UK.REC name
East Midlands - Derby Research Ethics Committee
REC reference
13/EM/0442
Date of REC Opinion
30 Dec 2013
REC opinion
Further Information Favourable Opinion