Abstract
The identification of new treatments for primary pulmonary arterial hypertension (PAH) is a critical unmet need since there is no a definitive cure for this disease yet. Due to the complexity of PAH, a wide set of methods are necessary to assess the response to a pharmacological intervention. Thus, a rigorous protocol is crucial when experimental studies are designed. In the present experimental protocol, a stepwise approach was followed in a monocrotaline-induced PAH model in the rat, moving from the dose finding study of treatment compounds to the recognition of the onset of disease manifestation, in order to identify when to start a curative treatment. A complete multidimensional evaluation of treatment effects represented the last step. The primary study endpoint was the change in right ventricular systolic pressure after 14 days of treatment; echocardiographic and biohumoral markers together with heart and pulmonary arterial morphometric parameters were considered as secondary efficacy and/or safety endpoints and for the evaluation of the biologic coherence in the different results.
Highlights
Subject Area: More specific subject area: Protocol name: Reagents/tools: Experimental design: Trial registration Ethics: Medicine and Dentistry Rare disease, primary pulmonary arterial hypertension; cardiology, respiratory disease
A stepwise approach was followed in a monocrotaline-induced pulmonary arterial hypertension (PAH) model in the rat, moving from the dose finding study of treatment compounds to the recognition of the onset of disease manifestation, in order to identify when to start a curative treatment
The primary study endpoint was the change in right ventricular systolic pressure after 14 days of treatment; echocardiographic and bioumoral markers together with heart and pulmonary arterial morphometric parameters were considered as secondary efficacy and/or safety endpoints and for the evaluation of the biologic coherence in the different results
Summary
Primary pulmonary arterial hypertension: Protocol to assess comprehensively in the rat the response to pharmacologic treatments. Deborah Novellia,, Francesca Fumagallia,, Lidia Staszewskya, Giuseppe Ristagnoa, Davide Olivaria, Serge Massona, Daria De Giorgioa, Sabina Ceriania, Roberta Massafraa, Francesco De Logub, Romina Nassinib, Marco Miliolic, Fabrizio Facchinettic, Silvia Cantonic, Marcello Trevisanic, Teresa Letiziad, Ilaria Russoa, Monica Salioa, Roberto Latinia,*. A Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy b Department of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, 50139, Florence, Italy c Chiesi Farmaceutici S.p.A., Corporate Pre-Clinical R&D, Largo F. Belloli 11/A, 43122, Parma, Italy d Endocrinology Laboratory, Luigi Sacco Hospital, Via Giovanni Battista Grassi 74, 20157, Milan, Italy
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