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

Use our guide to learn which trials are right for you!

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
sites
Marion, Ohio 43302
?
mi
from
Marion, OH
Click here to add this to my saved trials
Abington, Pennsylvania 19001
?
mi
from
Abington, PA
Click here to add this to my saved trials
Alexandria, Louisiana 71301
?
mi
from
Alexandria, LA
Click here to add this to my saved trials
Andalusia, Alabama 36420
?
mi
from
Andalusia, AL
Click here to add this to my saved trials
Arlington Heights, Illinois 60005
?
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
Aurora, Colorado 80010
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bradenton, Florida 32405
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
Caba, Buenos Aires
?
mi
from
Caba,
Click here to add this to my saved trials
Canton, Ohio 44718
?
mi
from
Canton, OH
Click here to add this to my saved trials
Chalmetta, Louisiana 70043
?
mi
from
Chalmetta, LA
Click here to add this to my saved trials
Corvallis, Oregon 97330
?
mi
from
Corvallis, OR
Click here to add this to my saved trials
Covington, Georgia 30014
?
mi
from
Covington, GA
Click here to add this to my saved trials
Dallas, Texas 75216
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Delray Beach, Florida 33445
?
mi
from
Delray Beach, FL
Click here to add this to my saved trials
Denver, Colorado 80262
?
mi
from
Denver, CO
Click here to add this to my saved trials
Doral, Florida 33136
?
mi
from
Doral, FL
Click here to add this to my saved trials
Duluth, Minnesota 55805
?
mi
from
Duluth, MN
Click here to add this to my saved trials
Everett, Washington 98208
?
mi
from
Everett, WA
Click here to add this to my saved trials
Falls Church, Virginia 22042
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Gainesville, Florida 32608
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Hattiesburg, Mississippi 39401
?
mi
from
Hattiesburg, MS
Click here to add this to my saved trials
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Houma, Louisiana 70360
?
mi
from
Houma, LA
Click here to add this to my saved trials
Kansas City, Kansas 66160
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Kettering, Ohio 45429
?
mi
from
Kettering, OH
Click here to add this to my saved trials
Las Vegas, Nevada 89135
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lincoln, Nebraska 68506
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Long Beach, California 90813
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Mobile, Alabama 36693
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Nashua, New Hampshire 03060
?
mi
from
Nashua, NH
Click here to add this to my saved trials
New Orleans, Louisiana 70115
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Northridge, California 91325
?
mi
from
Northridge, CA
Click here to add this to my saved trials
Omaha, Nebraska 68144
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Potsdam, New York 13676
?
mi
from
Potsdam, NY
Click here to add this to my saved trials
Rochester, New York 14615
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Seattle, Washington 98103
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Sioux Falls, South Dakota 57104
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
Spokane, Washington 99202
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Stamford, Connecticut 06905
?
mi
from
Stamford, CT
Click here to add this to my saved trials
Sylmar, California 91342
?
mi
from
Sylmar, CA
Click here to add this to my saved trials
Tomball, Texas 77375
?
mi
from
Tomball, TX
Click here to add this to my saved trials