Heart Failure Clinical Trial
Official title:
A Randomized, Double-blind, Multi-centre Study to Assess Safety and Efficacy of Incremental Doses of QGC001 in Patients With NYHA Class II/III Chronic Heart Failure (HF) With Left Ventricular Systolic Dysfunction Versus Placebo.
Heart Failure (HF) a common clinical condition characterized by either by a heart that does
not pump sufficiently or becomes stiff. A variety of mechanisms contribute to progressive
cardiac remodeling and dysfunction.
A new therapeutic approaches by preventing activation of the brain neuromodulatory pathway,
may lead to improve HF.
QCG001 is a prodrug of EC33, a aminopeptidase A (APA) inhibitor. QCG001 has been shown to be
an antihypertensive agent in animal models.
This study investigates the safety and efficacy of QGC001 in HF patients.
Despite advances in care, prognosis remains poor once overt Heart Failure (HF) has developed.
HF is a common clinical condition characterized by either by a heart that does not pump
sufficiently or becomes stiff and it is associates with higher incidences of patient illness
and death in both case. A variety of mechanisms contribute to progressive cardiac remodeling
and dysfunction.
A new therapeutic approaches by preventing activation of the brain neuromodulatory pathway,
may lead to improve HF.
QCG001 is a prodrug of EC33, a specific and selective of the aminopeptidase A (APA)
inhibitor. QCG001 has been shown to be an antihypertensive agent in animal models.
This study investigates the safety and efficacy of QGC001 up-titrated form 50mg twice daily
to a maximum of 500 mg twice daily, on patients with worsening chronic HF during 28 days and
7 days after discontinuation (day 35).
6 European countries are involved in this study (France, Netherlands, Germany, Norway, Poland
and United Kingdom) including 20 investigational hospitals. Patients would be followed during
35 days and inclusion period lasts until December 2017.
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