BAY 1021189 QT/QTc interval prolongation potential of vericiguat
Research type
Research Study
Full title
Study to clinically evaluate the QT/QTc interval prolongation potential of vericiguat in patients with stable coronary artery disease in a 2-arm, placebo-controlled, randomized, double-blind, double-dummy design including a vericiguat multiple-dose part with fixed up-titration periods and moxifloxacin as positive control (for assay sensitivity testing, nested into the placebo treatment)
IRAS ID
238986
Contact name
Jorg Taubel
Contact email
Sponsor organisation
Bayer AG
Eudract number
2017-003094-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 17 days
Research summary
Vericiguat is a new compound under development. It has been tested in several clinical trials in healthy volunteers and patients, but has not been approved by the competent authority for sale yet.
Vericiguat is developed for treatment of cardiovascular diseases especially heart failure or coronary artery disease. Heart failure is a disorder where the participant's heart is not able to sufficiently supply the participant's body with blood and oxygen in certain situations, because the pump function of the participant's heart is reduced. The most common cause for the heart not getting enough blood is coronary heart disease. In this disease, the coronary arteries become blocked, narrowed, or otherwise damaged. They can no longer supply the heart with all of the blood it needs.
The purpose of this study is to investigate whether multiple doses of vericiguat have an effect on the electrical conduction of the heart. This electrical activity and the heart rhythm can be easily measured and depicted by an electrocardiogram (ECG). Rhythmical changes of the electrical activity per heart beat are divided in intervals. The focus of this study is the effect of vericiguat on the QT interval. The QT interval describes in which time an electric impulse spreads over the ventricles and the heart returns to the initial state. During this time the cardiac muscle contracts, pumps the blood into the body and becomes slack again. A QT interval prolonged beyond a standard value is considered the cause for dangerous cardiac arrhythmia.
Either in the first or in the last treatment period the participant will receive placebo (a drug-free preparation) and moxifloxacin on one day. Moxifloxacin is a marketed antibiotic i.e. it fights bacteria in the body. Moxifloxacin is known to mildly prolong the QT interval and serves as so-called positive control (to confirm that the study is able to show a QT prolongation).
Approximately 72 participants will take part in the study in approximately 12 study centres in 4 different countries.
REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/0826
Date of REC Opinion
1 Jun 2018
REC opinion
Favourable Opinion