PARALLAX - A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients
The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving HF symptoms and functional capacity in patients with heart failure with preserved ejection fraction (HFpEF).
Heart & Vascular,
Heart & Vascular - Pharma Clinical Trials
John Mignone, MD, PhD
- Left ventricular ejection fraction (LVEF) ≥45% by echo within 6 months prior to study entry or during the screening epoch
- Symptom(s) of heart failure (HF) requiring treatment with diuretics (including loop, or thiazide diuretics, or mineralocorticoid antagonist [MRAs]) for at least 30 days prior to study entry
- NYHA class II-IV
- Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
- NT-proBNP > 220 pg/mL for patients with no atrial fibrillation/atrial flutter (AF) or >600 pg/mL for patients with AF
- KCCQ clinical summary score < 75
- Patients on ACEi or ARB therapy must have a history of HTN
- Any prior measurement of LVEF < 40%
- Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention (PCI) within 3 months or an elective PCI within 30 days prior to study entry
- Any clinical event within the 6 months prior to Visit 1 that could have reduced the LVEF (eg MI, coronary artery bypass graft [CABG]), unless an echo measurement was performed after the event confirming the LVEF to be ≥ 40% and EF ≥ 45% by the time of screening
- Current acute decompensated HF requiring therapy.
- Current use of renin inhibitor(s)
- History of hypersensitivity to LCZ696 or its components
- Patients with a known history of angioedema
- Walking distance primarily limited by non-cardiac comorbid conditions
- Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dL males and < 9.5 g/dL females, or body mass index (BMI) > 40 kg/m^2.
- Systolic blood pressure (SBP) ≥ 180 mmHg at study entry, or SBP >150 mmHg and <180 mmHg at study entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at study entry.
- Patients with HbA1c > 7.5% not treated for diabetes
- Patients with prior major organ transplant or intent to transplant (ie on transplant list)
- eGFR < 30 ml/min/1.73 m^2 as measured by MDRD at screening
- Serum potassium > 5.2 mmol /L at study entry
- History or presence of any other disease with a life expectancy of < 3 years
- Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception
Other protocol-defined inclusion/exclusion criteria may apply.
Charlene Boisjolie, RN