Work program


WP1 : Coordination of clinical studies and centres

The main goal of this work package is to coordinate the multi-centre observational cohort study (WP2) and the proof of concept interventional study (WP3), including the coordination of the regulatory and ethical aspects, trial sponsoring and insurance, study documents design, quality control of the cohort studies and the trial.
In addition, this WP will ensure the study governance and logistical management of oversight committees (Steering, Data safety and monitoring (DSMB) and event committees) interacting with WP 6.


WP2 : Cohorts studies for Diagnosis and risk prediction

In order to validate, retrospectively and prospectively, the ability of distinct ‘omics BM’ fingerprint(s) to predict the development of HF and other commonly associated co-morbidities in older people with increased cardiovascular risk and to diagnose asymptomatic HF, the specific objectives of this WP is to define specific informative cases and controls within the available cohorts and acquire new data-sets for replication.

WP3 : Prediction of therapeutic response

This WP will investigate, in a randomised trial, whether a biomarker ‘fingerprint’ can predict the therapeutic and/or adverse response to a candidate therapy administered to retard the progression of cardiovascular disease amongst older patients at high risk of developing HF. This WP will also develop a pre-specified prospective collaboration with another FP7 funded trial with complementary aims (PRIORITY).


WP4 : Biobanking, and bio-informatical analysis

Work package 4 aims to coordinate the bio-banking and perform the bio-informatical modelling for integration of BM and phenotype data, the latter quality controlled and statistically analysed in WP6. The UM Biobank is ISO9001-certified and uses web-based worldwide database system ATOS. We will bioinformatically analyze, in concert with WP6, the BM profiles generated by WP5 for their validity in predicting disease (heart failure, metabolic state), survival and treatment efficacy.


WP5 : Bioassay

Biomarker analysis is the central theme of this call and therefore it is imperative that all analytical methods and assays are rigorously validated in order to fully support the clinical work packages 2, 3 and 4, ensuring that their identification of superior biomarker signatures is based on solid, reliable biomarker data. The nature of ‘omics based’ research is such that the discovered biomarkers come from numerous disciplines, utilising multiple measurement techniques. The candidate list of biomarkers has been proposed by members of the consortium through identification within the partners own research combined with detailed literature studies and solid clinical data.


WP6 : Data management and statistical analysis

The WP6 will be in charge of managing data issued from clinical trials and ‘omics-based’ research as well as introducing standards and creating algorithms for the analysis to be performed.
This include the determination of the phenotypes that will be considered in cohorts, the development of standard operational procedures (SOPs) for database management and data cleaning, the setup of a central server and running statistical analysis for the production of statistical reports which will be distributed to the HOMAGE consortium and to the DSMC (Data safety and monitoring committee of the European Commission.

WP7 : Industrial Applications, regulatory consultation and market research

Introduction of novel medical devices is related to intensive research even after the product was clinically validated and launched. Its acceptance is related to a "critical mass" of high quality research data, convincing public health authorities, insurances and scientific societies of clinical and cost effectiveness as well as product safety. Consideration of a novel medical device in diagnostic and/or therapeutic guidelines is a prerequisite for its broad application. In this work package the prerequisites for reliable BM detection systems and the development of ready to use assay kits will be established.


WP8 : Dissemination

  • Promote integration and exchanges within and outside the HOMAGE consortium
  • Translate the results of the systematic review and of the observational trial into clinical recommendations and guidelines for the multidisciplinary global care of HF patients.
  • Disseminate of the findings to the scientific and business community, health care professionals and patient organizations
  • Manage intellectual property issues arising from the project.


WP9 : Management and Coordination

  • To set up an effective management framework for the HOMAGE consortium, this will ensure the progress of the project towards its planned objectives;
  • To act as the interface between the HOMAGE consortium and the European Commission;
  • To ensure that all actions are performed correctly and within the rules and regulations established by the European Commission and the Consortium Agreement, including financial and legal management, and to ensure that the received funds are correctly distributed and accounted for;
  • To ensure the work and tasks are performed on time, within budget and to the highest quality and create an early warning system.
  • To keep each partner, including the Commission, fully informed about the project status, scientific issues, the work planning (adjustments) and all other issues which are important and relevant to partners in order to obtain maximum transparency and achieve synergy of the cooperation; to ensure that all partners are informed of all important and impacting information that can influence the outcome of the project.