Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:45 - Any
Updated:3/15/2019
Start Date:June 15, 2018
End Date:January 15, 2020
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com
Phone:(+) 1-888-8422937

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A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of the Oral sGC stImulator Vericiguat to Improve Physical Functioning in Activities of Daily Living in Patients With Heart Failure and Preserved Ejection Fraction (VITALITY-HFpEF)

The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in
patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical
limitation score) compared to placebo after 24 weeks of treatment.


Inclusion Criteria:

- Previous diagnosis of chronic heart failure (HF)

- HF decompensation within 6 months prior to randomization, defined as hospitalization
for HF or intravenous (IV) diuretic treatment for HF without hospitalization.

- N-terminal pro brain natriuretic peptide (NT-proBNP) ≥300 or brain natriuretic peptide
(BNP) ≥100 pg/mL in sinus rhythm, or NT-proBNP

≥600 or BNP ≥200 pg/mL in atrial fibrillation within 30 days prior to randomization

- Diagnostic criteria of HFpEF by echocardiography assessed within 12 months prior to
randomization (most recent measurement must be used to determine eligibility with no
interim event signaling potential deterioration in ejection fraction)

- Left ventricular ejection fraction (LVEF) ≥45% and

- Structural changes indicated by at least one of the following parameters:

- Left ventricle (LV) hypertrophy (any of the following: intraventricular
septal or posterior wall thickness ≥1.1 cm, and/or LV mass index ≥115 g/m*2
in male and ≥95 g/m*2 in female), or

- Left atrium (LA) enlargement (any of the following: left atrial volume (LAV)
index ≥29 ml/m*2, or LAV >58 mL in male and >52 mL in female patients, or LA
area >20 cm*2, or LA diameter >40 mm in male and >38 mm in female patients)

- NYHA class II or III at randomization

Exclusion Criteria:

- Clinical instability at randomization, defined by

- Any IV treatment within 24h prior to randomization, and/or

- SBP ≥160 mmHg

- SBP <110 mmHg and/or DBP <40 mmHg and/or symptomatic hypotension

- Resting heart rate (HR) <50 or ≥100 beats per minute (bpm)

- Use of IV inotropes at any time between qualifying HF event and randomization

- Previous diagnosis of reduced ejection fraction (EF) (EF <40%)

- Hypertrophic obstructive cardiomyopathy, acute myocarditis, amyloidosis, sarcoidosis,
or pericardial disease

- Primary valvular heart disease requiring surgery or intervention, or within 3 months
after valvular surgery or intervention, or active endocarditis

- Acute coronary syndrome, including unstable angina, Non ST-elevation myocardial
infarction or ST-elevation myocardial infarction, or Coronary artery bypass grafting
(CABG) within 60 days prior to randomization, or indication for Percutaneous coronary
intervention or CABG at the time of randomization

- Symptomatic carotid stenosis, or transient ischemic attack or stroke within 60 days
prior to randomization

- Complex congenital heart disease

- Non-cardiac comorbidity (any of the following)

- Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m*2 calculated by
Modification of Diet in Renal Disease formula

- Hepatic insufficiency classified as Child-Pugh B or C

- Morbid obesity with a body mass index >45 kg/m*2

- Malignancy or other non-cardiac condition limiting life expectancy to <1 year,
per physician judgment

- Requires continuous home oxygen for severe pulmonary disease or has interstitial
lung disease

- Patients with allergies, intolerance or hypersensitivity to investigational drug
or any of the excipients

- Concurrent or anticipated use of nitrates or NO donors, phosphodiesterase type V
(PDE5) inhibitors, or a Soluble guanylate cyclase (sGC) stimulator
We found this trial at
53
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Owensboro, Kentucky 42303
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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11701 San Jose Blvd # 32
Jacksonville, Florida 32223
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Alexandria, Virginia 22306
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Annapolis, Maryland 21401
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Baytown, Texas 77521
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Beverly Hills, California 90211
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Bossier City, Louisiana 71111
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9868 State Road 7
Boynton Beach, Florida 33472
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6100 Pointe West Boulevard West
Bradenton, Florida 34209
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Camp Hill, Pennsylvania 17011
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Carmichael, California 95608
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Colorado Springs, Colorado 80907
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Daytona Beach, Florida 32117
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Detroit, Michigan 48202
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Germantown, Tennessee 38138
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Hammond, Louisiana 70403
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Huntsville, Texas 77340
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Hutchinson, Kansas 67502
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Jackson, Mississippi 39209
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1029 West Meeting Street
Lancaster, South Carolina 29720
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Libertyville, Illinois 60048
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Lincoln, Nebraska 68506
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New Orleans, Louisiana 70112
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Oak Ridge, Tennessee 37830
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Picayune, Mississippi 39466
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Poughkeepsie, New York 12601
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Ramos Mejía, Buenos Aires
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Warwick, Rhode Island 02886
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3347 North State Road 7
Wellington, Florida 33449
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