Trial Condition(s):

Heart Failure, Chronic heart failure with reduced ejection fraction

A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001) (VICTORIA)

Bayer Identifier:

16493

ClinicalTrials.gov Identifier:

NCT02861534

EudraCT Number:

2016-000671-25

Study Completed

Trial Purpose

This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven study of vericiguat (MK-1242) in participants with heart failure with reduced ejection fraction (HFrEF). The primary hypothesis is vericiguat (MK-1242) is superior to placebo in increasing the time to first occurrence of the composite of cardiovascular (CV) death or heart failure (HF) hospitalization in participants with HFrEF.

Inclusion Criteria
- History of chronic HF (New York Heart Association [NYHA] Class II-IV) on standard therapy before qualifying HF decompensation
- Previous HF hospitalization within 6 months prior to randomization or intravenous (IV) diuretic treatment
for HF (without hospitalization) within 3 months.
- Brain natriuretic peptide (BNP) levels: sinus rhythm-≥ 300 pg/mL; atrial fibrillation-≥ 500 pg/mL and Nterminal
pro-Brain Natriuretic Peptide (NT proBNP) levels: sinus rhythm- ≥ 1000 pg/mL; atrial fibrillation - ≥ 1600 pg/mL within 30 days prior to randomization
- Left ventricular ejection fraction (LVEF) of <45% assessed within 12 months prior to randomization by any method If female, is not of reproductive potential or agrees to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug by complying with one of the following: practice abstinence from heterosexual activity or use (or have her partner use) acceptable contraception during heterosexual activity.
Exclusion Criteria
- Clinically unstable at the time of randomization as defined by either the administration of any IV treatment within 24 hours prior to randomization, and/or systolic blood pressure (SBP) <100 mmHg or symptomatic hypotension
- Current or anticipated use of long-acting nitrates or nitric oxide (NO) donors including isosorbide dinitrate, isosorbide 5-mononitrate, pentaerythritol tetranitrate, nicorandil or transdermal nitroglycerin (NTG) patch, and molsidomine
- Current or anticipated use of phosphodiesterase type 5 (PDE5) inhibitors such as vardenafil, tadalafil, and sildenafil
- Current use or anticipated use of a soluble guanylate cyclase (sGC) stimulator such as riociguat
- Known allergy or sensitivity to any sGC stimulator
- Awaiting heart transplantation (United Network for Organ Sharing Class 1A / 1B or equivalent), receiving continuous IV infusion of an inotrope, or has/anticipates receiving an implanted ventricular assist device
- Primary valvular heart disease requiring surgery or intervention, or is within 3 months after valvular surgery or intervention
- Hypertrophic obstructive cardiomyopathy
- Acute myocarditis, amyloidosis, sarcoidosis, Takotsubo cardiomyopathy
- Post-heart transplant cardiomyopathy
- Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia
- Acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction [NSTEMI], or ST elevation myocardial infarction [(STEMI]) or coronary revascularization (coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI]) within 60 days, or indication for coronary revascularization at time of randomization
- Symptomatic carotid stenosis, transient ischemic attack (TIA) or stroke within 60 days
- Complex congenital heart disease
- Active endocarditis or constrictive pericarditis
- Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2 or chronic dialysis
- Severe hepatic insufficiency such as with hepatic encephalopathy
- Malignancy or other non-cardiac condition limiting life expectancy to <3 years
- Require continuous home oxygen for severe pulmonary disease
- Current alcohol and/or drug abuse

Trial Summary

Enrollment Goal
5050
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Morioka, Japan, 020-0066

Status
Completed
 
Locations

Investigative Site

Sendai, Japan, 983-8512

Status
Completed
 
Locations

Investigative Site

Funabashi, Japan, 273-8588

Status
Completed
 
Locations

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Itabashi-ku, Japan, 173-8610

Status
Completed
 
Locations

Investigative Site

Meguro-ku, Japan, 153-0051

Status
Completed
 
Locations

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Ota-ku, Japan, 143-8541

Status
Completed
 
Locations

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Yokohama, Japan, 227-8501

Status
Completed
 
Locations

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Fukui, Japan, 910-8526

Status
Completed
 
Locations

Investigative Site

Shizuoka, Japan, 420-8527

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 464-8547

Status
Completed
 
Locations

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Nagoya, Japan, 457-8510

Status
Completed
 
Locations

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Kyoto, Japan, 601-1495

Status
Completed
 
Locations

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Osaka, Japan, 530-0001

Status
Completed
 
Locations

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Hirakata, Japan, 573-0153

Status
Completed
 
Locations

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Suita, Japan, 565-0862

Status
Completed
 
Locations

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Matsue, Japan, 690-8509

Status
Completed
 
Locations

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Okayama, Japan, 700-8557

Status
Completed
 
Locations

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Kanonji, Japan, 769-1695

Status
Completed
 
Locations

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Kitakyushu, Japan, 800-0296

Status
Completed
 
Locations

Investigative Site

Nagasaki, Japan, 852-8501

Status
Completed
 
Locations

Investigative Site

Miyazaki, Japan, 880-2102

Status
Completed
 
Locations

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Sayama, Japan, 350-1305

Status
Completed
 
Locations

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Sagamihara, Japan, 252-5188

Status
Completed
 
Locations

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Uji, Japan, 611-0041

Status
Completed
 
Locations

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Osaka, Japan, 543-0035

Status
Completed
 
Locations

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Naha, Japan, 902-8511

Status
Completed
 
Locations

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Wako, Japan, 351-0102

Status
Completed
 
Locations

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Bunkyo-ku, Japan, 113-8431

Status
Completed
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8655

Status
Completed
 
Locations

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Yokohama, Japan, 222-0036

Status
Completed
 
Locations

Investigative Site

Suita, Japan, 564-8565

Status
Completed
 
Locations

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Kishiwada, Japan, 596-0042

Status
Completed
 
Locations

Investigative Site

Takarazuka, Japan, 665-0873

Status
Completed
 
Locations

Investigative Site

Hamada, Japan, 697-8511

Status
Completed
 
Locations

Investigative Site

Kitakyushu, Japan, 805-8508

Status
Completed
 
Locations

Investigative Site

Kagoshima, Japan, 892-0822

Status
Completed
 
Locations

Investigative Site

Meguro-ku, Japan, 152-8902

Status
Completed
 
Locations

Investigative Site

Koga, Japan, 306-0041

Status
Completed
 
Locations

Investigative Site

Adachi-ku, Japan, 123-0845

Status
Completed
 
Locations

Investigative Site

Shibuya-ku, Japan, 150-0013

Status
Completed
 
Locations

Investigative Site

Shinjuku-ku, Japan, 160-0023

Status
Completed
 
Locations

Investigative Site

Hachioji, Japan, 192-0918

Status
Completed
 
Locations

Investigative Site

Shinagawa-ku, Japan, 141-0001

Status
Completed
 
Locations

Investigative Site

Kawasaki, Japan, 211-8510

Status
Completed
 
Locations

Investigative Site

Yokohama, Japan, 247-8581

Status
Completed
 
Locations

Investigative Site

Toyama, Japan, 930-8550

Status
Completed
 
Locations

Investigative Site

Toyama, Japan, 930-0194

Status
Completed
 
Locations

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Kanazawa, Japan, 920-8530

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 454-8502

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 460-0001

Status
Completed
 
Locations

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Kyoto, Japan, 602-8026

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 558-8558

Status
Completed
 
Locations

Investigative Site

Higashiosaka, Japan, 578-8588

Status
Completed
 
Locations

Investigative Site

Suita, Japan, 565-0871

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 650-0047

Status
Completed
 
Locations

Investigative Site

Takarazuka, Japan, 665-0022

Status
Completed
 
Locations

Investigative Site

Kurume, Japan, 830-8543

Status
Completed
 
Locations

Investigative Site

Shimotsuke, Japan, 329-0498

Status
Completed
 
Locations

Investigative Site

Kawasaki, Japan, 211-8533

Status
Completed
 
Locations

Investigative Site

Yokohama, Japan, 232-0024

Status
Completed
 
Locations

Investigative Site

Kyoto, Japan, 602-8566

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 654-0026

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 812-8582

Status
Completed
 
Locations

Investigative Site

Funabashi, Japan, 274-8503

Status
Completed
 
Locations

Investigative Site

Matsudo, Japan, 270-2251

Status
Completed
 
Locations

Investigative Site

Takatsuki, Japan, 569-1096

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 655-0017

Status
Completed
 
Locations

Investigative Site

Matsuyama, Japan, 790-0062

Status
Completed
 
Locations

Investigative Site

Nahariya, Israel, 2210001

Status
Completed
 
Locations

Investigative Site

Frankfurt, Germany, 60596

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02114-2696

Status
Completed
 
Locations

Investigative Site

Sagamihara, Japan, 252-0375

Status
Completed
 
Locations

Investigative Site

Longueuil, Canada, J4N 1E1

Status
Completed
 
Locations

Investigative Site

Graz, Austria, 8036

Status
Completed
 
Locations

Investigative Site

St. Petersburg, Russia, 194354

Status
Completed
 
Locations

Investigative Site

Chesterfield, United Kingdom, S44 5DX

Status
Completed
 
Locations

Investigative Site

San Juan, Puerto Rico, 00921

Status
Completed
 
Locations

Investigative Site

PARIS cedex 10, France, 75475

Status
Completed
 
Locations

Investigative Site

Wroclaw, Poland, 50-981

Status
Completed
 
Locations

Investigative Site

Bergamo, Italy, 24127

Status
Completed
 
Locations

Investigative Site

El Palmar (Murcia), Spain, 30120

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Investigative Site

SNEEK, Netherlands, 8601 ZK

Status
Completed
 
Locations

Investigative Site

Malmö, Sweden, 205 02

Status
Completed
 
Locations

Investigative Site

Svendborg, Denmark, DK-5700

Status
Completed
 
Locations

Investigative Site

Oslo, Norway, 0424

Status
Completed
 
Locations

Investigative Site

Praha 4, Czech Republic, 140 21

Status
Completed
 
Locations

Investigative Site

Kistarcsa, Hungary, 2143

Status
Completed
 
Locations

Investigative Site

Istanbul, Turkey, 34304

Status
Completed
 
Locations

Investigative Site

Alexandroupoli, Greece, 68100

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 02841

Status
Completed
 
Locations

Investigative Site

Lausanne, Switzerland, 1011

Status
Completed
 
Locations

Investigative Site

Espoo, Finland, 02740

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 11217

Status
Completed
 
Locations

Investigative Site

Sarawak, Malaysia, 93400

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 119074

Status
Completed
 
Locations

Investigative Site

Christchurch, New Zealand, 8140

Status
Completed
 
Locations

Investigative Site

Dublin, Ireland, DUBLIN 4

Status
Completed
 
Locations

Investigative Site

Querétaro, Mexico, 76000

Status
Completed
 
Locations

Investigative Site

Johannesburg, South Africa, 2157

Status
Completed
 
Locations

Investigative Site

Murdoch, Australia, 6150

Status
Completed
 
Locations

Investigative Site

Mar del Plata, Argentina, B7600FZN

Status
Completed
 
Locations

Investigative Site

Many locations, Chile

Status
Completed
 
Locations

Investigative Site

Many locations, Colombia

Status
Completed
 
Locations

Investigative Site

Hong Kong, Hong Kong, China

Status
Completed
 
Locations

Investigative Site

Manila, Philippines, 1000

Status
Completed
 
Locations

Investigative Site

Kashihara, Japan, 634-8522

Status
Completed
 
Locations

Investigative Site

Aki-gun, Japan, 735-8585

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 654-0155

Status
Completed
 
Locations

Investigative Site

Tachikawa, Japan, 190-0014

Status
Completed
 
Locations

Investigative Site

Niigata, Japan, 950-2087

Status
Completed
 
Locations

Investigative Site

Higashiibaraki, Japan, 311-3193

Status
Completed
 
Locations

Investigative Site

Kanazawa, Japan, 920-8650

Status
Completed
 
Locations

Investigative Site

Iwakuni, Japan, 740-8510

Status
Completed
 
Locations

Investigative Site

Shinjuku-ku, Japan, 162-8666

Status
Completed
 
Locations

Investigative Site

Nakagami-gun, Japan, 901-2393

Status
Completed
 
Locations

Investigative Site

Koshigaya, Japan, 343-8555

Status
Completed
 
Locations

Investigative Site

Nagano, Japan, 388-8004

Status
Completed
 
Locations

Investigative Site

Nagasaki, Japan, 850-8555

Status
Completed
 
Locations

Investigative Site

Oita, Japan, 870-0192

Status
Completed
 
Locations

Investigative Site

Shobara, Japan, 727-0013

Status
Completed
 
Locations

Investigative Site

Yonago, Japan, 683-8605

Status
Completed
 
Locations

Investigative Site

Nagaoka, Japan, 940-8621

Status
Completed
 
Locations

Investigative Site

Many locations, China

Status
Completed
 
Locations

Investigative Site

Many locations, Ukraine

Status
Completed
 
Locations

Investigative Site

Many locations, Peru

Status
Completed
 
Locations

Investigative Site

Many locations, Guatemala

Status
Completed
 

Trial Design