EFFICACY AND SAFETY OF LCZ696 COMPARED TO VALSARTAN, ON MORBIDITY AND MORTALITY IN HEART FAILURE PATIENTS WITH PRESERVED EJECTION FRACTIO
- Conditions
- -I50I50
- Registration Number
- PER-010-15
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
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).
• Any prior measurement of LVEF < 45%.
• Acute coronary syndrome (including MI), cardiac surgery, other major
CV surgery, or urgent percutaneous coronary intervention (PCI) within
the 3 months prior to Visit 1 or an elective PCI within 30 days prior to
Visit 1.
• Patients who have had an MI, coronary artery bypass graft (CABG) or
other event within the 6 months prior to Visit 1 that could have reduced
their EF unless an echo measurement performed after the event
confirms a LVEF ≥45%.
• Current acute decompensated HF requiring augmented therapy with
diuretics, vasodilators and/or inotropic drugs.
• 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.
• History of hypersensitivity to any of the study drugs or to drugs of
similar chemical classes.
• Patients with a known history of angioedema.
• Probable alternative diagnoses that in the opinion of the investigator
could account for patient’s HF symptoms (i.e., dyspnea, fatigue) such
as significant pulmonary disease (including primary pulmonary
hypertension), anemia or obesity. Specifically, patients with the below
are excluded:
• severe chronic obstructive pulmonary disease (COPD) (i.e., requiring
home oxygen, chronic nebulizer therapy, chronic oral steroid therapy
or hospitalized for pulmonary decompensation within 12 months) or
• hemoglobin (Hgb) <10 g/dl, or
• body mass index (BMI) > 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method