Aliskiren vs enalapril in chronic heart failure

• Research type

  Research Study

• Full title

  A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV). (CSPP100F2301, ATMOSPHERE)

• IRAS ID

  15996

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2008-004104-31

• ISRCTN Number

  Not submitted

• Research summary

  Heart failure affects over 700,000 people in the UK, with an estimated 68,000 new cases occurring each year, and is a major cause of hospitalisation and death.Drugs such as enalapril (also used to treat high blood pressure) are commonly used to treat heart failure, but there is a need for better treatments in order to improve outcomes. The aim of this study is to determine whether treatment with a new drug, aliskiren (currently used to treat high blood pressure) on top of conventional treatment for chronic heart failure, when taken alone or combined with enalapril, is better or the same at treating chronic heart failure than enalapril alone. Eligible patients who have provided written agreement to take part in the study will enter a 3 - 12 week run-in period, during which all patients will be exposed to aliskiren and enalapril together, in order to ensure the combination is well-tolerated, that there is sufficient blockade of the renin-angiotensin-aldosterone system (RAAS) and that proven therapy is not withheld. Patients will then be randomly allocated to receive either aliskiren alone, enalapril alone or a combination of aliskiren/enalapril (as well as their usual treatment for chronic heart failure). Neither the doctor nor the patient will know which study treatment has been allocated.Patients will be in the study for 2 - 4 years, and will visit the clinic up to a total of 19 times over that period. The main assessments will include physical examinations, blood pressure and pulse measurements, ECGs (electrocardiograms) and safety blood tests. Approximately 7,041 patients from across the world will be recruited into this study, of which 50 will be from the UK.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  09/H0706/22

• Date of REC Opinion

  3 Apr 2009

• REC opinion

  Further Information Favourable Opinion