LCZ696 versus enalapril on daily physical activity
Research type
Research Study
Full title
A multi-centre, prospective, randomised, double-blind study to assess the impact of sacubitril/valsartan vs. enalapril on daily physical activity using a wrist worn actigraphy device in adult chronic heart failure patients.
IRAS ID
207352
Contact name
Ray Meleady
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2016-003085-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 19 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. HF is a major public health problem associated with a high mortality rate, frequent hospitalizations, and poor quality of life (QOL).
50% of patients die within 5 years and due to the progressive nature of the disease (progression of breathlessness, fatigue, swelling etc) there is a negative impact on the health related QOL.
Eligible patients who agree and consent to take part in the study will continue on their regular therapy for their condition but any angiotensin receptor blockers (ARBs) and/or angiotensin converting enzyme inhibitor (ACEI) will be replaced by the study medication.
Sacubitril/valsartan (also called LCZ696) constitutes the first of a new class of drugs - Angiotensin Receptor-Neprilysin Inhibitors (ARNIs) for the management of HF. It has been recently approved by the EMA for the treatment of HF in patients with reduced ejection fraction (HFrEF) by demonstrating its superiority over the ACEI enalapril in terms of the state of the disease and the number of deaths in a population. In the same study QOL assessments were compared however these were from randomization which was after a 6-8 week long run-in period during which patients received target doses of enapril and then LCZ696 and therefore no true baseline QOL was captured.
The aim of this study is to assess differences between sacubitril/valsartan versus enalapril in increasing physical activity in a non-seated position in HFrEF patients by means of a wrist-worn accelerometry device from 2 weeks before until 12 weeks after start of the treatment (sacubitril/valsartan or enalapril)
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0026
Date of REC Opinion
1 Feb 2017
REC opinion
Favourable Opinion