Overview

Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients

Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
LCZ 696
Sacubitril and valsartan sodium hydrate drug combination
Criteria
Inclusion Criteria:

- Age ≥ 18 years; CHF with New York Heart Association class II-IV; left ventricular
ejection fraction ≤ 35%; on beta blockers

Exclusion Criteria:

- Potassium > 5.2 mmol/l; estimated glomerular filtration rate < 30 ml/min/1.73 m2;
systolic blood pressure <100 mmHg or > 180 mmHg; history of intolerance to recommended
target doses of angiotensin converting enzyme inhibitors or angiotensin receptor
blockers

Other protocol-defined inclusion/exclusion criteria may apply.