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INHERITANCE – PRECARDIA. Pavia Meeting June 15, 2012. Aim. - Study the impact of ACE inhibitors (ACEi) in relatives who carry a mutation but have not yet developed DCM through a double-blind randomized (parallel-group) multicenter trial.

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inheritance precardia

INHERITANCE – PRECARDIA

Pavia Meeting

June 15, 2012

slide2
Aim.

- Study the impact of ACE inhibitors (ACEi) in relatives who carry a mutation but have not yet developed DCM through a double-blind randomized (parallel-group) multicenter trial.

- To extend the medical impact of predictive genetic testing in DCM (direct therapeutic impact).

Hypothesis.

- ACEi may delay or prevent the occurence of DCM in these participants (preclinical stage).

“INHERITANCE- PRECARDIA” Studyor PRE clinical mutation CARriers from families with Dilated cardiomyopathy and ACE inhibitors
precardia study timetable
“PRECARDIA” Study :Timetable
  • Submission to the sponsor (INSERM-ECRIN):Final approval obtained the10th of January 2011
  • Submission to the Competent Authorities via the Voluntary Harmonisation Procedure (to the Head of Medicines Agencies HMA – unified process): submitted June 2011, obtained 15 August 2011
  • Submission to national competent authority in France (AFSSAPS):
    • Final agreement obtained in Paris 31 August 2011
  • Submission to local ethical committees: submitted June2011 for Pavia and Paris
    • Final agreement obtained in Paris 05 October 2011
  • Agreement / convention document :

- with Servier: signed; with Brahms: underway

- tripartite agreements between INSERM/ ECRIN partner or other CTU/ local institution** : under way

** ECRIN partner or other CTU not part of the local institution

precardia study inclusion in paris
“PRECARDIA” Study : inclusion in Paris
  • First participant included:
    • 1st December 2011
  • Total participants included by the 15th June 2012:
    • 3 participants
    • (all with a LMNA mutation, from 3 different families and 3 different mutations)
    • (2 with isolated LVED enlargement and 1 with isolated systolic dysfunction (EF50%)
update submissions 1 2
Update – Submissions1/2

INHERITANCE – PRECARDIA

update submissions 2 2
Update – Submissions2/2

INHERITANCE – PRECARDIA

update agreements
Update - Agreements

First draft sent by the sponsor.

INHERITANCE – PRECARDIA

slide8
Submission to the VHP: 27/JUN/2011       

Authorization from the VHP: 15/AUG/2011

any comments
Any comments?

PRECARDIA

precardia study budget
Cost related to drug/placebo production and distributionare covered by Servier company.

Cost related to coordination, insurance and monitoring will be covered by Paris centre. Preparation/submission to Health Agencies and Ethical committees, was also covered by Paris.

Cost related to SUSAR reporting, hospitals overcosts and clinical research associates (inclusion participants and entering data into DB) will be covered by local investigators.

BUDGET:

Each center received a budget for participating to several workpackages in FP7 / Inheritance network

Total cost of PRECARDIA: 405,000 euros including 222,000 euros for Paris

“PRECARDIA” Study :Budget
precardia study budget ecrin local investigators initial evaluation in 2010 should be update euros
“PRECARDIA” Study Budget ECRIN / local investigators: initial evaluation in 2010 (should be update, euros)

by Léa Stankovski, INSERM/ECRIN

budget update
Budget (update)
  • Insurance:
    • Paid by Paris (for France, Italy, Spain, Denmark, Netherlands) about 45,000 euros
    • Pending for Germany and UK

PRECARDIA

budget for monitoring
Budget for monitoring
  • Final answer from Inserm/UE: not possible for Paris to pay other partners within the network
  • Half of the required budget (~40 KE) however available from Paris-Inheritance budget through the use of indirect costs
  • Half of the required budget? (~40 KE)
      • Re-allocation directly from UE/Pavia?
      • Use of final part of UE funding?
      • Extra budget?