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) - Vericiguat-Subjects With Heart Failure With Reduced Ejection Fraction

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Treatment of chronic heart failure with reduced ejection fraction (HFrEF)
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 4872
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

August 22, 2016

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•In order to be eligible for participation in this trial, the subject must:
•1\. Provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
•2\. Be male or female, aged 18 years or older on the day of signing informed consent.
•3\. Have a history of chronic HF (NYHA class II\-IV) on standard therapy before qualifying HF decompensation.
•4\. Have a previous HF hospitalization within 6 months prior to randomization or IV diuretic treatment for HF (without hospitalization) within 3 months prior to randomization.
•5\. Have brain natriuretic peptide (BNP) or NT\-proBNP levels within 30 days prior to randomization as follows:
•NT\-proBNP BNP
•Sinus Rhythm \> or \= 1000 pg/mL \> or \= 300 pg/mL
•Atrial Fibrillation \> or \= 1600 pg/mL \> or \= 500 pg/mL
•6\. Have a left ventricular ejection fraction (LVEF) of \<45% assessed within 12 months prior to randomization by any method (most recent measurement must be used to determine eligibility).

•The subject must be excluded from participating in the trial if the subject:
•1\. Is clinically unstable at the time of randomization as defined by:
•a. Administration of any intravenous treatment within 24 hours prior to randomization, and/or
•b. Systolic blood pressure (SBP) \<100 mmHg or symptomatic hypotension.
•2\. Has concurrent or anticipated use of long\-acting nitrates or NO donors including isosorbide dinitrate, isosorbide 5\-mononitrate, pentaerythritol tetranitrate, nicorandil or transdermal nitroglycerin (NTG) patch, and molsidomine.
•3\. Has concurrent use or anticipated use of phosphodiesterase type 5 (PDE5\) inhibitors such as vardenafil, tadalafil, and sildenafil.
•4\. Has concurrent use or anticipated use of a sGC stimulator such as riociguat.
•5\. Has known allergy or sensitivity to any sGC stimulator.
•6\. Is 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.
•Cardiac Comorbidity