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


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)
Therapeutic Area Cardiomyopathy, Cardiac Failure, Heart Failure, Cardiovascular Disease
Principal Investigator Jenica Upshaw, MD
Min Age 18 Years
Gender Both
Contact Angelo DeNofrio
617 636-9458
More Information https://clinicaltrials.gov/ct2/show/NCT02861534

Overview

This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven study of vericiguat (MK-1242) in participants with heart failure 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.

Study Details

Inclusion Criteria

  • Patients age ≥ 18 who carry a diagnosis of chronic heart failure (NYHA Class II-IV) and are on standard therapy
  • Hospitalized within the last 6 months for heart failure or have had intravenous (IV) diurtetic treatment for heart failure within the last 3 months.

Exclusion Criteria

  • 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
  • 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

Study Requirements

This study is expected to last up to three (3) years. You will receive either the study drug MK-1242 or a matching placebo (sugar pill). You will have a 1 in 2 chance of receiving the placebo (like flipping a coin). You can expect to visit the study doctor about twelve (12) times. Each visit is estimated to last at least thirty (30) minutes but no more than two (2) hours. When possible, will try to schedule your study visits to occur on days when you are already coming to Tufts Medical Center. In the beginning of the study you will be seen more frequently; however as the study goes on, you will be come to Tufts Medical Center about every 4 months. When you come in for a study visit, we may do some or all of the following medical procedures:
  • Review your medical history and perform a physical examination
  • Check your blood pressure and heart rate
  • Collect blood samples for routine laboratory tests and pharmacokinetic sample (a test to quantify how much of the study drug is in your body). Depending on the specific visit, the amount of blood taken will range from one (1) teaspoon (5 mL) to up to four (4) teaspoons (20 mL).
  • Perform an Electrocardiogram (ECG) - a test that produces a tracing of your heartbeat
  • Review your study medication and any side effects you have felt
  • Review any medical events (such as hospital admissions) that have happened to you since your last visit
  • Provide you with more study drug and instructions on how to take
  • For females only – a urine pregnancy test