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EducationThe Faculty Graduate SchoolsGraduate School of Medical SciencesJunior Scientific Masterclass
University Medical Center Groningen

New drug for heart failure?

Introduction

'How to develop a potential novel drug, CD-NP, for the treatment of patients with acute decompensated heart failure?'

HF is a clinical syndrome characterized by typical symptoms (e.g. breathlessness, ankle swelling and fatigue) that may be accompanied by signs (e.g. elevated jugular venous pressure, pulmonary crackles and peripheral edema) caused by a structural and/or functional cardiac abnormality. It affects approximately 2% of the adult population. Patients with HF have a poor prognosis with high hospitalisation and mortality rates up to 30% mortality within q year after hospitalization for acute heart failure. In patients with chronic heart failure, implementation of evidence based treatment (inhibitors of the renin-angiotensin-aldosterone system (RAAS) and beta-blockers) and implantable devices have led to a reduction in the hospitalization rate and, to a lesser extent lower mortality. In contrast, no drugs have been proven to improve clinical outcome in patients with acute decompensated heart failure. Several drugs have been tested in the last decades, but large randomized clinical trials failed to show an effect on clinical outcome. These failures might have been related to the drug, but might also been caused by inappropriate study design or by not selecting the right patient for the right drug.

CD-NP is a chimeric natriuretic peptide in which the 15-amino acid C-terminal tail of Dendroaspis natriuretic peptide is fused to the 22-amino acid human C-type natriuretic peptide. The rationale for its design was to create a peptide with the beneficial cardiovascular and renal effects of native natriuretic peptides, but without a clinically significant hypotensive response. With these properties, this drug is of potential benefit for patients with acute decompensated heart failure. The drug has been extensively studies pre-clinically and first studies in healthy volunteers are performed.

Aim

In this course the pathophysiology of acute decomeonsated heart failure is studied. JSM students are challenged to create of a research plan, including phase IIa/b and phase II trials to develop CD-NP for the treatment of acute decompensated heart failure. This includes selection of patients, endpoints, sample size calculations, and design and set-up of clinical drug trials.

Content

In this course, medical students will have the possibility to learn from specialists about heart failure and drug development and will be able to visit a phase I clinic where novel drugs are tested in healthy volunteers.

As an assignment, students will prepare their own drug development plan for CD-NP for the treatment of patients with acute decompensated heart failure. The author of the most exciting drug development plan will be helped to start a pilot project in our research group that is specialized in novel drug development for patients with heart failure. Students interested in scientific research with an immediate clinical impact are encouraged to join this program.

Students will be rewarded with 2 ECTS if they have participated fully and professionally, to be judged by the coordinator of the course and handed in a drug development plan of sufficient quality.

ECTS

Students will be rewarded with 2 ECTS if they have participated fully and professionally, to be judged by the coordinator of the course and handed in a drug development plan of sufficient quality.

Programme

The assignment will be explained and supervised by the lecturer during the meetings. A special final meeting will be planned for all the students.

Registration

Third year medicine and dentistry students with interest in clinical research can enroll on Nestor.

Contact person

Prof. dr. A.A. Voors, Department of Cardiology, University Medical Center Groningen
e-mail: a.a.voors umcg.nl

Last modified:30 March 2017 3.09 p.m.
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