A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:45 - Any
Updated:2/17/2019
Start Date:January 8, 2017
End Date:December 4, 2019
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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A 24-week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Effect of LCZ696 on NT-proBNP, Exercise Capacity, Symptoms and Safety Compared to Individualized Medical Management of Comorbidities in Patients With Heart Failure and Preserved Ejection Fraction

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 exercise capacity and HF symptoms in patients with heart failure
with preserved ejection fraction (HFpEF).


Inclusion Criteria:

- 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 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

Exclusion Criteria:

- Any prior measurement of LVEF ≤ 40%, under stable conditions

- 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%

- Current (within 30 days from Visit 1) acute decompensated HF requiring therapy.

- Current (within 30 days from Visit 1) use of renin inhibitor(s), dual RAS blockade or
LCZ696

- History of hypersensitivity to LCZ696 or its components

- Patients with a known history of angioedema

- Walk distance primarily limited by non-cardiac comorbid conditions at study entry

- 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 (or equivalent plasma potassium value) 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.
We found this trial at
44
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Gainesville, Florida 32608
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Abington, Pennsylvania 19001
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Alexandria, Louisiana 71301
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Andalusia, Alabama 36420
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Arlington Heights, Illinois 60005
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Aurora, Colorado 80010
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Beverly Hills, California 90211
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Boston, Massachusetts 02118
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Bradenton, Florida 32405
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Caba, Buenos Aires
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Canton, Ohio 44718
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Chalmetta, Louisiana 70043
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Corvallis, Oregon 97330
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Covington, Georgia 30014
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Dallas, Texas 75216
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Delray Beach, Florida 33445
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Denver, Colorado 80262
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Doral, Florida 33136
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Duluth, Minnesota 55805
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Everett, Washington 98208
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Falls Church, Virginia 22042
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Hattiesburg, Mississippi 39401
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Hollywood, Florida 33021
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Houma, Louisiana 70360
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Kansas City, Kansas 66160
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Kettering, Ohio 45429
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Las Vegas, Nevada 89135
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Long Beach, California 90813
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Marion, Ohio 43302
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Mobile, Alabama 36693
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Nashua, New Hampshire 03060
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New Orleans, Louisiana 70115
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Northridge, California 91325
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Rochester, New York 14615
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