Clinical Trials

​Current ongoing VMP sponsored clinical trials​

Colchicine Cardiovascular Outcomes Trial (COLCOT)

Indications
Reduction of cardiovascular risk in patients with atherosclerotic coronary artery disease (CAD). 

Objectives

  • The primary objective of this study is to determine whether long-term treatment with colchicine reduces rates of cardiovascular events in patients after myocardial infarction (MI). 
  • The secondary objective is to determine the safety of long-term treatment with colchicine in this patient population. The tertiary objective is to evaluate links between soluble and genetic biomarkers and treatment effects. 

Principle Investigator: Dr. Ziyad Ghazzal 
Sponsor: Montreal Heart Institute 

A Randomised, Double-blind Placebo Controlled Trial Comparing the Effect of Intravenous Ferric Carboxymaltose on Hospitalisations and Mortality in Iron Deficient Patients Admitted for Acute Heart Failure (AFFIRM-AHF) ​


Short title
Assessment oF Ferric carboxymaltose to Improve moRbidity and Mortality in iron- deficient patients hospitalised for Acute Heart Failure (AFFIRM-AHF)

Indication
Acute heart failure (AHF) constitutes a clinically and economically challenging problem. The prognosis of these patients remains poor, and so far, major clinical trials have failed to improve outcomes in these patients. The current treatment of AHF remained virtually unchanged in recent decades. iron deficiency (ID) is frequent among patients with HF and predicts poor outcome . Although, there are premises that correction of ID in AHF patients could improve clinical outcomes, it has not been investigated to date.
This clinical trial aims to investigate the effect of IV FCM, relative to placebo on recurrent HF hospitalisations and CV death up to 52 weeks after randomisation in iron deficient subjects hospitalised for AHF.

  • Primary Objective(s): To evaluate, relative to placebo, the effect of intravenous (IV) ferric carboxymaltose (FCM) on repeated heart failure (HF) hospitalisations and cardiovascular (CV) death. 
  • Secondary Objective(s)
    • To evaluate, relative to placebo, the effect of IV FCM on:
    • HF hospitalisations, CV hospitalisations, CV mortality and all-cause mortality.
    • Quality of life and New York Heart Association Classification (NYHA).
    • Tolerability and safety.

Principle investigator: Dr. Mohamad Samir Arnaout 
Sub-investigator (1): Dr. Hadi Skouri 
Sub-investigator (2): Dr. Hussain Ismaeel 

Sponsor: Vifor 

Completed clinical trials-VMP


A multicenter, randomized, double-blind, placebo controlled phase III study to evaluate the efficacy, safety and tolerability of serelaxin when added to standard therapy in acute heart failure patients (RELAX-ASIA)

Rationale and study endpoints
The purpose of this study is to evaluate the efficacy, safety and   tolerability of intravenous infusion of 30 μg/kg/day serelaxin for 48 hours within 16 hours of clinical presentation, when added to standard therapy, in approximately 1,520 Asian AHF patients randomized to receive serelaxin or placebo to demonstrate superiority in early improvement in signs and symptoms of congestion and reduction in worsening heart failure (WHF) as evaluated by a clinical composite as the primary endpoint. 

In addition, the study will also assess the effect of serelaxin on the cardiovascular (CV) and all-cause deaths as listed as secondary endpoint. 

Principle investigator: Dr. Hadi Skouri  
Sub-investigator: Dr. Hussain Ismaeel 

Sponsor: Novartis 

A multicenter, randomized, open label, parallel group study comparing pre-discharge and posT-discharge tReatment initiation with LCZ696 in heArt failure patieNtS with reduced ejectIon-fracTion hospItalized for an acute decOmpensation eveNt (ADHF) (the TRANSITION study)

Purpose
This trial is to explore two modalities of treatment initiation (Pre- discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an acute decompensated heart failure (ADHF) episode.

Primary Objective
Evaluate the proportion of patients in the Pre- and Post-discharge treatment initiation groups achieving the target dose of 200 mg LCZ696 twice daily at the end of the week-10 after randomization (Treatment Epoch), regardless of previous temporary dose interruption or down-titration.
 
Secondary Objectives
  • Assess the proportion of patients that, regardless of previous dose interruption or down-titration during the Treatment Epoch, achieved and maintained either the 2 highest doses of LCZ696 bid for at least 2 weeks leading to week 10 after randomization.
  • Assess the proportion of patients that, regardless of previous dose interruption or down-titration during the Treatment Epoch, achieved and maintained any dose of LCZ696 for at least 2 weeks leading to week 10 after randomization.
  • Assess the proportion of patients permanently discontinued from study drug, due to Adverse Events, during the 10-week Treatment.

Principle investigator: Dr. Marwan Refaat 
Sub-investigator: Dr. Hadi Skouri 

Sponsor: Novartis 

Research Coordinator: Ghida Iskandarani