Clinical investigation of medicinal products for the treatment of acute heart failure - Scientific guideline

This document provides guidance on the main regulatory requirements for the development of a medicinal product for the treatment of acute heart failure in adults. It focueses mainly on pharmacological intervention of left ventricular dysfunction with or without concomitant right ventricular dysfunction.

Keywords: Acute heart failure, acute decompensated heart failure, acute heart failure syndromes, chronic heart failure, dyspnoea, B-type natriuretic peptide (BNP)

Current effective version

Guideline on clinical investigation of medicinal products for the treatment of acute heart failure - Revision 1

Adopted Reference Number: CPMP/EWP/2986/03 Rev. 1 Summary:

The current document is a revised version of this Addendum and the text has been updated in relation to certain factors. In particular, patient characteristics that impact on outcome of AHF trials and their evaluation such as, need for standardisation of time of enrolment in clinical trials, time-points to assess symptoms, use of the composite endpoints, value of invasive haemodynamic measurements and role of natriuretic peptides are addressed.

Document history - Revision 1 (current version)

Guideline on clinical investigation of medicinal products for the treatment of acute heart failure - Revision 1

Adopted Reference Number: CPMP/EWP/2986/03 Rev. 1 Summary:

The current document is a revised version of this Addendum and the text has been updated in relation to certain factors. In particular, patient characteristics that impact on outcome of AHF trials and their evaluation such as, need for standardisation of time of enrolment in clinical trials, time-points to assess symptoms, use of the composite endpoints, value of invasive haemodynamic measurements and role of natriuretic peptides are addressed.

Draft guideline on clinical investigation of medicinal products for the treatment of acute heart failure - Revision 1

Draft: consultation closed Consultation dates: 15/10/2012 to 15/04/2013 Reference Number: CHMP/EWP/2986/03 Rev. 1 Summary:

This is a revised version of the addendum to the note for guidance on the clinical investigation of medicinal products for the treatment of cardiac failure. It is intended to provide updated guidance on the evaluation of drugs in the treatment of acute heart failure on those aspects that are not adequately covered in the guideline on chronic heart failure. The text has been updated in relation to the factors in particular patient characteristics that impact outcome of acute-heart-failure trials and their evaluation.

Draft concept paper on the need for revision of the addendum on acute cardiac failure of the note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure (CPMP/EWP/2986/03)

Draft: consultation closed Consultation dates: 20/05/2010 to 31/08/2010 Reference Number: EMA/CHMP/EWP/215701/2010

Document history - First version

Note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure - Addendum on acute cardiac failure

Adopted Reference Number: CPMP/EWP/2986/03 Legal effective date: 01/01/2005