Heart Failure With Preserved Ejection Fraction
Conditions
Interventions
investigational material(s)
Generic name etc : LCZ696
INN of investigational material : -
Therapeutic category code : 214 Antihypertensives
Dosage and Administration for Investigational material : LCZ
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Left ventricular ejection fraction (LVEF) >=45% by echo during screening epoch or within 6 months prior to study entry. *Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at least 30 days prior to study entry. *Current symptom(s) of HF. *Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram. *Elevated NT-proBNP.
Exclusion criteria
Exclusion criteria: *Any prior measurement of LVEF =45%. *Current acute decompensated HF requiring therapy. *Patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin inhibitor. *Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) 40 kg/m2. *Systolic blood pressure (SBP) >= 180 mmHg at entry, or SBP >150 mmHg and <180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at entry. Other protocol-defined inclusion/exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Cumulative number of primary composite events of cardiovascular (CV) death and total (first and recurrent) HF hospitalizations. [ Time Frame: Total follow up time (up to 57 months) ] The primary objective of this study is to compare LCZ696 to valsartan in reducing the rate of the composite endpoint of CV death and total (first and recurrent) HF hospitalizations, in HF patients (New York Heart Association [NYHA] Class II-IV) with preserved ejection fraction (left ventricular ejection fraction [LVEF] >=45%). The treatment arm with the lower rate of events will be deemed as having a successful response. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Change in the clinical summary score from baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline, 8 months ] Evaluation of change from baseline to month 8 in KCCQ a most sensitive, specific, and responsive health-related quality of life measure for heart failure symptoms and physical limitations. safety efficacy Change from baseline to Month 8 in New York Heart Association (NYHA) functional class [ Time Frame: Baseline, 8 months ] Evaluation of change from baseline to Month 8 in NYHA functional class, a well established grading scale used to classify a HF patients' level of functionality based on the signs and symptoms of HF exhibited by the patient. safety efficacy Time to first occurance of a composite renal endpoint [ Time Frame: Total follow up time (up to 57 months) ] Evaluate significance of outcome modifying agents in worsening renal dysfunction. Composite renal endpoint defined as follows: renal death, or reaching ESRD, or >=50% decline in eGFR relative to baseline safety efficacy Time to all-cause mortality [ Time Frame: Total follow up time (up to 57 months) ] Evaluation of the time to all cause death. | — |
Countries
Asia except Japan, Europe, Japan, North America, South America
Outcome results
None listed