Study to evaluate the effect of LCZ696 compared to individualized medical therapy for comorbidities in Heart failure with preserved Ejection Fraction (HFpEF) patients
- Conditions
- Heart Failurewith preserved Ejection Fraction (HFpEF)MedDRA version: 20.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2016-003410-28-IT
- Lead Sponsor
- OVARTIS PHARMA SERVICES AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2572
left ventricular ejection fraction (LVEF) >40% by echo within 6 months prior to study entry or during the screening epoch - Symptom (s) of heart failure (HF) requiring treatment eith diuretics (Including loop or thiazide diuretics or mineralocorticold 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
Other protocol defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 403
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2097
Any prior measurement of LVEF < 40% under stable condition
-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 eithin 30 days prior to study entry.
- any clinical event within the 6 months prior to Visit 1 that could have reduced the LVEF unless an echo measurement was performed after the event confirmng the LVEF to be>40%
- current (eithin 30 days from visit 1 ) acute decompensated HF requiring theray, use of renin inhibitor(s), dual RAS blockade or LCZ696
-Hisoty of hypersensitivy to LCZ696 or its components
-patients with a known history of angioederma
-Walk distance primarily limited by non-cardiac comorbid conditions at visit 1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method