None listed
Conditions
Interventions
You will be
asked to take 2 tablets 2 times a day.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
55 Years to 100 Years
Inclusion criteria
Inclusion criteria: Written informed consent must be obtained before any assessment is performed. • ≥55 years of age, male or female • LVEF ≥45% by echocardiogram (echo) during the screening epoch, or within 6 months prior to Visit 1(any local LVEF measurement made using echo only) • Symptom(s) of HF requiring treatment with diuretic(s) for HF ≥30 daysprior to Visit 1 • Current symptom(s) of HF (NYHA Class II-IV) at Visit 1 • Structural heart disease evidenced by one or both of the following echo findings (any local measurement made during the screening epoch or within the 6 months prior to Visit 1): • 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 • left ventricular hypertrophy (LVH) defined by septal thickness or posterior wall thickness ≥1.1 cm • Patients with at least one of the following: • a HF hospitalization (defined as HF as the major reason for hospitalization or treatment for HF lasting ≥12 hours and including intravenous [IV] diuretics at a healthcare facility) within 9 months prior to Visit 1, • Visit 1 elevated NT-proBNP (>300 pg/ml for patients not in atrial fibrillation (AF) or >900 pg/ml for patients in AF on the Visit 1 ECG).
Exclusion criteria
Exclusion criteria: • Any prior measurement of LVEF 40 kg/m2 • Patients with any of the following: • systolic blood pressure (SBP) ≥ 180 mmHg at Visit 1, or • SBP >150 mmHg and <180 mmHg at Visit 1 unless the patient
Countries
Australia, Austria, Belgium, Bulgaria, Canada, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Korea South, Spain, Switzerland, United Kindgdom, United States
Contacts
Public ContactAlexandra Lopez De negri
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed