Clinical investigation of medicinal products in the treatment of chronic heart failure - Scientific guideline

Guidance for the clinical investigation of medicinal products in the treatment of cardiac failure.

Keywords: Heart failure, left ventricular function, mortality, morbidity, hospitalisation

Current effective version

Guideline on clinical investigation of medicinal products for the treatment of chronic heart failure - Revision 2

Adopted Reference Number: CPMP/EWP/235/95 Rev.2 Legal effective date: 01/03/2018 Summary:

This guideline replaces the Note for Guidance on clinical investigation of medicinal products for the treatment of cardiac failure (CPMP/EWP/235/95, Rev 1).

Document history

Guideline on clinical investigation of medicinal products for the treatment of chronic heart failure - Revision 2

Adopted Reference Number: CPMP/EWP/235/95 Rev.2 Legal effective date: 01/03/2018 Summary:

This guideline replaces the Note for Guidance on clinical investigation of medicinal products for the treatment of cardiac failure (CPMP/EWP/235/95, Rev 1).

Draft guideline on clinical investigation of medicinal products for the treatment of chronic heart failure - Revision 2

Draft: consultation closed Consultation dates: 11/02/2016 to 31/08/2016 Reference Number: EMA/CHMP/392958/2015 Summary:

This guideline addresses the EU regulatory position on the clinical development of new medicinal products in the treatment of patients with chronic heart failure (CHF).

Overview of comments received on draft Guideline on clinical investigation of medicinal products for the treatment of chronic heart failure (CPMP/EWP/235/95, Rev.2)

Reference Number: EMA/547655/2017

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

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

Concept paper on the need for revision of the note for guidance on the clinical investigation of medicinal products for the treatment of cardiac failure - Revision 1

Draft: consultation closed Consultation dates: 01/03/2013 to 31/05/2013 Reference Number: EMA/CHMP/87576/2013 Summary:

Chronic heart failure encompasses heterogeneous groups of patients with a wide spectrum of symptoms and different causes. The Committee for Medicinal Products for Human Use guideline on the clinical investigation of medicinal products for the treatment of cardiac failure addresses the development issues in this specific patient population. Recently, it became apparent that the scope of the guideline should be widened to include patients who are encountered in clinical practice and not previously addressed and to elaborate on the endpoints to be studied.

Note for guidance on clinical investigation of medicinal products in the treatment of cardiac failure - Revision 1

Adopted Reference Number: CPMP/EWP/235/95, Rev 1 Legal effective date: 01/06/2000