LCZ696 vs individualized medical therapy for patients with HFpEF
Research type
Research Study
Full title
A 24-week, randomized, double-blind, multi-center, parallel group, active controlled study to evaluate the effect of LCZ696 on NT-proBNP, symptoms, exercise function and safety compared to individualized medical management of comorbidities in patients with heart failure and preserved ejection fraction.
IRAS ID
223470
Contact name
C. Piers Clifford
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2016-003410-28
Duration of Study in the UK
2 years, 5 months, 20 days
Research summary
Heart failure (HF) is a major public health problem associated with a high mortality rate, frequent hospitalizations, and poor quality of life (QoL). Heart failure can be defined as having either reduced or preserved ejection fraction. Heart failure with preserved ejection fraction (HFpEF) is an area of particularly high unmet need since no therapy has been proven to offer a mortality benefit to date. Current management is limited to individualized treatment of their co-morbidities.
This study aims to see if LCZ696 is any better than individualized medical therapy for comorbidities (additional disease(s) or disorder(s) occurring alongside heart failure) at controlling NT-proBNP (a protein found in the blood, used as an indicator of heart failure severity), heart failure symptoms and exercise capacity in patients with HFpEF.
Patients will be sorted into one of three arms according to what medical treatment, if any, they are already receiving: Angiotensin Converting Enzyme inhibitor (ACEi), Angiotensin Receptor Blocker (ARB) or no Renin Angiotensin system inhibitor (RASi) (meaning they have not been taking any medication that acts on the Renin Angiotensin system up until joining the study). Patients will then be randomly allocated to receive either LCZ or a comparator. Patients in the ACEi arm will receive either LCZ696 or enalapril (an ACEi). Patients in the ARB arm will receive either LCZ696 or valsartan (an ARB), and patients in the no RASi arm will receive either LCZ696 or placebo. The allocated treatment will be 'double blind' meaning that neither the doctor nor the patient will know which has been allocated.
Patients will be in the study for around 6 months and will visit the clinic up to 9 times. The main assessments will include physical examinations, blood pressure and pulse measurements, electrocardiograms, blood and urine tests and questionnaires to assess impact of heart failure on patients’ QoL.REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/0792
Date of REC Opinion
27 Jun 2017
REC opinion
Further Information Favourable Opinion