Condition Congestive heart failure with preserved ejection fraction
A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction
To evaluate the effect of LCZ696 compared to valsartan in the reduction of CV death and rate of HF hospitalizations in patients with HFpEF. This study will serve as a registration trial for LCZ696 as a treatment for patients with HFpEF
Key Inclusion Criteria
1. ≥55 years of age
2. LVEF >45% by echo within 6 months prior to Visit 1
3. Symptom(s) requiring treatment with diuretic(s) for HF ≥30 days prior to Visit 1.
4. Current symptom(s) of HF (NYHA class II-IV) at Visit 1.
5. Structural heart disease evidenced by one or both of the following echo findings
a. left atrial (LA) enlargement defined by at least one of the following: LA width ≥3.8 cm or LA length ≥5.0 cm or LA area ≥20 cm2 or LA volume ≥55 mL or LA volume index ≥29 mL/m2
b. left ventricular hypertrophy (LVH) defined by septal thickness or posterior wall thickness ≥1.1 cm
6. Patients with at least one of the following:
a. a HF hospitalization (defined as HF as the major reason for hospitalization or treatment for HF lasting ≥12 hours and including treatment with intravenous (IV) diuretics at a healthcare facility) within 9 months prior to Visit 1,
b. Visit 1 elevated NT-proBNP (>300 pg/ml for patients not in AF or >900 pg/ml for patients in AF on the Visit 1 ECG).
Key Exclusion Criteria
- Patients who require treatment with 2 or more of the following: an ACEI, an ARB or arenininhibitor
- Patients with a known history of angioedema.
- Evidence of right sided HF in the absence of left-sided structural heart disease.
- Patients with an implantable cardioverter-defibrillator or cardiac resynchronization therapy (CRT) device.