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)

  • STATUS
    Recruiting
  • sponsor
    Merck Sharp & Dohme Corp., (a subsidiary of Merck & Co. Inc.)
Updated on 25 March 2021

Summary

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)

Description

This study is evaluating how effective the study drug MK-1242 (vericiguat) is in patients with heart failure.

Details
Condition Heart Failure
Clinical Study IdentifierTX145020
SponsorMerck Sharp & Dohme Corp., (a subsidiary of Merck & Co. Inc.)
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

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
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