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
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).
English (EN) (318.89 KB - PDF)
Document history
Guideline on clinical investigation of medicinal products for the treatment of chronic heart failure - Revision 2
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).
English (EN) (318.89 KB - PDF)
Draft guideline on clinical investigation of medicinal products for the treatment of chronic heart failure - Revision 2
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).
English (EN) (266 KB - PDF)
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)
English (EN) (299.74 KB - PDF)
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)
English (EN) (113.81 KB - PDF)
Note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure - Addendum on acute cardiac failure
English (EN) (209.08 KB - PDF)
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
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.
English (EN) (96.22 KB - PDF)
Note for guidance on clinical investigation of medicinal products in the treatment of cardiac failure - Revision 1
English (EN) (63.39 KB - PDF)
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