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

This study is currently recruiting participants.
Verified November 2017 by Merck Sharp & Dohme Corp.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02861534
First Posted: August 10, 2016
Last Update Posted: November 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Bayer
Canadian VIGOUR Centre
Duke Clinical Research Institute
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven study of vericiguat (MK-1242) in participants with 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.

Condition Intervention Phase
Heart Failure Chronic Heart Failure With Reduced Ejection Fraction Drug: Vericiguat Drug: Placebo for Vericiguat Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) - VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure Hospitalization [ Time Frame: Up to approximately 3.5 years ]

Secondary Outcome Measures:
  • Time to the First Occurrence of CV Death [ Time Frame: Up to approximately 3.5 years ]
  • Time to the First Occurrence of HF Hospitalization [ Time Frame: Up to approximately 3.5 years ]
  • Time to Total HF Hospitalizations (including frst and recurrent events) [ Time Frame: Up to approximately 3.5 years ]
  • Time to First Occurrence of Composite Endpoint of All-cause Mortality or HF Hospitalization [ Time Frame: Up to approximately 3.5 years ]
  • Time to All-cause Mortality [ Time Frame: Up to approximately 3.5 years ]

Estimated Enrollment: 4872
Actual Study Start Date: September 20, 2016
Estimated Study Completion Date: January 24, 2020
Estimated Primary Completion Date: January 10, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vericiguat
Starting dose of 2.5 mg taken orally once daily with food, on a background of standard of care. Dose will be uptitrated to 5 mg and to 10 mg.
Drug: Vericiguat
2.5, 5.0, or 10.0 mg orally once daily
Other Name: MK-1242
Placebo Comparator: Placebo
Starting dose of 2.5 mg taken orally once daily with food, on a background of standard of care. Dose will be uptitrated to 5 mg and to 10 mg.
Drug: Placebo for Vericiguat
2.5, 5.0, or 10.0 mg orally once daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 N-terminal 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
  • Participated in another interventional clinical study and treatment with another investigational product ≤30 days prior to randomization or plans to participate in any other trial/investigation during the duration of this study
  • Mental or legal incapacitation and is unable to provide informed consent
  • Immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is involved with this study
  • Interstitial Lung Disease
  • Breastfeeding or plans to breastfeed during the course of the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861534


Contacts
Contact: Toll Free Number 1-888-577-8839

  Show 145 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Bayer
Canadian VIGOUR Centre
Duke Clinical Research Institute
Investigators
Study Director: Mahesh J. Patel, MD Merck Sharp & Dohme Corp.
Study Chair: Paul W. Armstrong, MD Canadian VIGOUR Centre - University of Alberta
Principal Investigator: Christopher M. O'Connor, MD Inova Heart and Vascular Institute
Principal Investigator: Burkert Pieske, MD Charité University Medicine and German Heart Center
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02861534     History of Changes
Other Study ID Numbers: 1242-001
2016-000671-25 ( EudraCT Number )
First Submitted: August 5, 2016
First Posted: August 10, 2016
Last Update Posted: November 27, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases