Status:
COMPLETED
LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The study will assess the effects of 36 weeks of treatment with LCZ696 compared to valsartan on N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) in patients with chronic heart failure and preserve...
Eligibility Criteria
Inclusion
- Patients with documented stable chronic heart failure (NYHA II-IV):
- LVEF ≥ 45% (local measurement, assessed by echocardiography, MUGA, CT scan, MRI or ventricular angiography)
- the ejection fraction must have been obtained within 6 months prior to randomization or after any MI or other event that would affect ejection fraction.
- Plasma NT-proBNP \> 500 pg/ml at Visit 1.
- Patients with documented stable chronic heart failure (NYHA II-IV).
- Patients receiving ACE inhibitors (ACEi), an angiotensin receptor blockers (ARB) and/or a beta blockers must be on a stable dose of these medications stable for the 1 month period prior to Visit 1.
- Patients must be on diuretic therapy prior to Visit 1 (flexible dosing is permitted).
- Patients with a controlled systolic BP, defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment if they are on three or more medications to control BP at randomization (Visit 2).
- Patients with at least one of the following symptoms at the time of screening (Visit 1):
- Dyspnea on exertion
- Orthopnea
- Paroxysmal nocturnal dyspnea
- Peripheral edema
- Patients must have an eGFR ≥ 30 ml/min/1.73 m2 at Visit 1 (calculated by the Modification of Diet in Renal Disease formula).
- Patients with a potassium ≤5.2 mmol/l at Visit 1.
Exclusion
- Patients with a prior LVEF reading \<45%, at any time.
- Patients who require treatment with both an ACE inhibitor and an ARB.
- Isolated right heart failure due to pulmonary disease.
- Dyspnea and/or edema from non-cardiac causes, such as lung disease, anemia, or severe obesity.
- Presence of hemodynamically significant mitral and /or aortic valve disease.
- Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic stenosis.
- Presence of hypertrophic obstructive cardiomyopathy.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT00887588
Start Date
November 1 2009
End Date
December 1 2011
Last Update
August 25 2015
Active Locations (81)
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1
Novartis Investigative Site
Little Rock, Arkansas, United States, 72205
2
Novartis Investigative Site
Chicago, Illinois, United States, 60657
3
Novartis Investigative Site
Detroit, Michigan, United States, 48201
4
Novartis Investigative Site
Grand Island, Nebraska, United States, 68803