Vericiguat-Subjects With Heart Failure With Reduced Ejection Fraction
Research type
Research Study
Full 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)
IRAS ID
212944
Contact name
Martin Cowie
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2016-000671-25
Duration of Study in the UK
3 years, 1 months, 0 days
Research summary
Heart failure (HF) is a leading cause of cardiovascular morbidity and mortality being a major public health problem worldwide. HF affects more than 10% of the population over 70 years of age in developed countries. Chronic HF leads to hospitalisation, substantially worsened prognosis, and remains unfavourable despite standard of care treatments.
Heart Failure with Reduced Ejection Fraction (HfrEF) is characterised by the compromised ability of the heart to eject blood sufficiently.
Vericiguat belongs to a novel class of oral stimulator of the soluble guanylate cyclase (sGC) enzyme which induces synthesis of a signaling molecule called cyclic guanosine monophosphate (cGMP). cGMP plays an important role in regulating various cardiovascular processes in HF.
sGC is insufficiently stimulated in patients with HF due to a reduced nitric oxide (NO) availability. Vericiguat’s dual mode of action sensitizes sGC to the body’s own NO and can increase sGC activity in the absence of NO. It works by widening the pulmonary arteries (the blood vessels that connect the heart to the lungs), making it easier for the heart to pump blood through the lungs.
The purpose of this phase III trial is to study how effective and safe vericiguat is as compared to placebo, on a background of standard of care.
Approximately 4872 men and women aged over 18 years with chronic HFrEF will be randomised in this trial. They will be taking one tablet of vericiguat or matching placebo daily, at a starting dose of 2.5 mg, then increased to 5mg up to the target dose of 10 mg. The trial will last approximately 39 months with an average participation for each patient of about 18 months.
The study is funded by Merck Sharp & Dohme Limited and will take place at 8 study centres in the UK.
REC name
London - Harrow Research Ethics Committee
REC reference
16/LO/1822
Date of REC Opinion
22 Nov 2016
REC opinion
Further Information Favourable Opinion