QUantum genomics Incremental Dosing in Heart Failure - QUID-HF
Research type
Research Study
Full title
A Phase II randomized, placebo controlled, double-blind, multi-centre study to assess safety and efficacy of incremental doses of QGC001 in patients upon discharge from hospital admission for worsening chronic heart failure with left ventricular systolic dysfunction Short title: QUantum genomics Incremental Dosing in Heart Failure Acronym “ QUID-HF”
IRAS ID
203772
Contact name
Chim Lang
Contact email
Sponsor organisation
Quantum Genomics
Eudract number
2015-005607-92
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
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 10 investigational hospitals. Patients would be followed during 35 days and inclusion period lasts 10 months.REC name
Scotland B REC
REC reference
16/SS/0128
Date of REC Opinion
17 Oct 2016
REC opinion
Further Information Favourable Opinion