Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | November 2013 |
End Date: | August 2014 |
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
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.
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.
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.
We found this trial at
25
sites
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