Brief Summary
The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =\< 35%).
Brief Title
This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure
Categories
Completion Date
Completion Date Type
Actual
Conditions
Heart Failure With Reduced Ejection Fraction
Eligibility Criteria
Inclusion Criteria:
* Patients must give written informed consent before any assessment is performed.
* Outpatients ≥ 18 years of age, male or female.
* Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction (EF =\< 35%) and elevated BNP.
* Patients must be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks.
* Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks.
Exclusion Criteria:
* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
* History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.
* Previous history of intolerance to recommended target doses of ACEIs or ARBs
* Known history of angioedema.
* Requirement of treatment with both ACEIs and ARBs.
* Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).
* Symptomatic hypotension and/or a SBP \< 100 mmHg.
* Estimated GFR \< 30 mL/min/1.73m2 as measured by the simplified MDRD formula
* Serum potassium \> 5.2 mmol/L.
Other protocol-defined inclusion/exclusion criteria may apply.
* Patients must give written informed consent before any assessment is performed.
* Outpatients ≥ 18 years of age, male or female.
* Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction (EF =\< 35%) and elevated BNP.
* Patients must be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks.
* Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks.
Exclusion Criteria:
* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
* History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.
* Previous history of intolerance to recommended target doses of ACEIs or ARBs
* Known history of angioedema.
* Requirement of treatment with both ACEIs and ARBs.
* Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).
* Symptomatic hypotension and/or a SBP \< 100 mmHg.
* Estimated GFR \< 30 mL/min/1.73m2 as measured by the simplified MDRD formula
* Serum potassium \> 5.2 mmol/L.
Other protocol-defined inclusion/exclusion criteria may apply.
Inclusion Criteria
Inclusion Criteria:
* Patients must give written informed consent before any assessment is performed.
* Outpatients ≥ 18 years of age, male or female.
* Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction (EF =\< 35%) and elevated BNP.
* Patients must be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks.
* Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks.
inclusion/
* Patients must give written informed consent before any assessment is performed.
* Outpatients ≥ 18 years of age, male or female.
* Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction (EF =\< 35%) and elevated BNP.
* Patients must be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks.
* Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks.
inclusion/
Gender
All
Gender Based
false
Keywords
chronic heart failure
cardiovascular death
hospitalization
outcome study
BNP
KCCQ
eGFR
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01035255
Org Class
Industry
Org Full Name
Novartis
Org Study Id
CLCZ696B2314
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Patients With Chronic Heart Failure and Reduced Ejection Fraction
Primary Outcomes
Outcome Description
Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.
Outcome Measure
Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
Outcome Time Frame
up to 51 months
Secondary Ids
Secondary Id
2009-015834-31
Secondary Outcomes
Outcome Description
Number of patients - All-cause mortality. All-cause mortality is common in Heart Failure HF patients this measures how many patients had this event. The data is on FAS population up to March 31, 2014
Outcome Time Frame
up to 51 months
Outcome Measure
Number of Patients - All-cause Mortality
Outcome Description
Number of patients reported with adjudicated primary causes of death. The data is on Randomization population up to March 31, 2014
Outcome Time Frame
up to 51 months
Outcome Measure
Number of Patients Reported With Adjudicated Primary Causes of Death
Outcome Description
Change from baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Outcome Time Frame
Baseline, Month 8
Outcome Measure
Change From Baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
Outcome Description
Number of patients with first confirmed renal dysfunction
Outcome Time Frame
up to 51 months
Outcome Measure
Number of Patients With First Confirmed Renal Dysfunction
Outcome Description
Percentage of participants with New Onset of Atrial Fibrillation The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis).
Outcome Time Frame
up to 51 months
Outcome Measure
Percentage of Participants With New Onset of Atrial Fibrillation (AF)
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ronald Zolty
Investigator Email
rzolty@montefiore.org
Investigator Phone