Primary pulmonary arterial hypertension: Protocol to assess comprehensively in the rat the response to pharmacologic treatments.

Alanine transaminase Blood pressure Cardiac biomarkers Creatinine Echocardiography Heart histology Monocrotaline Morphometric analysis of pulmonary arteries Randomization Right ventricular systolic pressure Sample size

Journal

MethodsX
ISSN: 2215-0161
Titre abrégé: MethodsX
Pays: Netherlands
ID NLM: 101639829

Informations de publication

Date de publication:
2020
Historique:
received: 13 11 2019
accepted: 12 12 2019
entrez: 30 1 2020
pubmed: 30 1 2020
medline: 30 1 2020
Statut: epublish

Résumé

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.

Identifiants

pubmed: 31993338
doi: 10.1016/j.mex.2019.100771
pii: S2215-0161(19)30347-4
pii: 100771
pmc: PMC6974770
doi:

Types de publication

Journal Article

Langues

eng

Pagination

100771

Informations de copyright

© 2019 The Authors.

Déclaration de conflit d'intérêts

Marco Milioli, Fabrizio Facchinetti, Silvia Cantoni, Marcello Trevisani are employees of Chiesi Farmaceutici S.p.A. The other authors have no conflicts of interest to declare.

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Auteurs

Deborah Novelli (D)

Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy.

Francesca Fumagalli (F)

Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy.

Lidia Staszewsky (L)

Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy.

Giuseppe Ristagno (G)

Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy.

Davide Olivari (D)

Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy.

Serge Masson (S)

Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy.

Daria De Giorgio (D)

Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy.

Sabina Ceriani (S)

Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy.

Roberta Massafra (R)

Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy.

Francesco De Logu (F)

Department of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, 50139, Florence, Italy.

Romina Nassini (R)

Department of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, 50139, Florence, Italy.

Marco Milioli (M)

Chiesi Farmaceutici S.p.A., Corporate Pre-Clinical R&D, Largo F. Belloli 11/A, 43122, Parma, Italy.

Fabrizio Facchinetti (F)

Chiesi Farmaceutici S.p.A., Corporate Pre-Clinical R&D, Largo F. Belloli 11/A, 43122, Parma, Italy.

Silvia Cantoni (S)

Chiesi Farmaceutici S.p.A., Corporate Pre-Clinical R&D, Largo F. Belloli 11/A, 43122, Parma, Italy.

Marcello Trevisani (M)

Chiesi Farmaceutici S.p.A., Corporate Pre-Clinical R&D, Largo F. Belloli 11/A, 43122, Parma, Italy.

Teresa Letizia (T)

Endocrinology Laboratory, Luigi Sacco Hospital, Via Giovanni Battista Grassi 74, 20157, Milan, Italy.

Ilaria Russo (I)

Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy.

Monica Salio (M)

Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy.

Roberto Latini (R)

Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy.

Classifications MeSH