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Relaxin mimetic in pulmonary hypertension associated with left heart disease: Design and rationale of Re-PHIRE
M. Ufnal, K. Connolly, M. Millegard, E. Surkova, M. Guazzi, D. Bonderman, J. Ezekowitz, F. Gustafsson, M. Ciurzyński, RL. Vilella, T. Ahmad, R. Gardner, P. Jansa, S. van Wijk, K. Kinugawa, E. Björklund, ZC. Jing, S. Rosenkranz
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu protokol klinické studie, časopisecké články
Grantová podpora
AstraZeneca
NLK
Directory of Open Access Journals
od 2014
Free Medical Journals
od 2014
PubMed Central
od 2015
Europe PubMed Central
od 2015
ProQuest Central
od 2014-09-01
Open Access Digital Library
od 2014-01-01
Open Access Digital Library
od 2014-09-01
Health & Medicine (ProQuest)
od 2014-09-01
Wiley-Blackwell Open Access Titles
od 2014
ROAD: Directory of Open Access Scholarly Resources
od 2014
PubMed
39829393
DOI
10.1002/ehf2.15203
Knihovny.cz E-zdroje
- MeSH
- cévní rezistence účinky léků MeSH
- dvojitá slepá metoda MeSH
- klinické zkoušky, fáze II jako téma MeSH
- lidé středního věku MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- plicní hypertenze * farmakoterapie patofyziologie etiologie MeSH
- randomizované kontrolované studie jako téma MeSH
- relaxin * analogy a deriváty MeSH
- senioři MeSH
- srdeční selhání * komplikace patofyziologie farmakoterapie MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
AIMS: Despite receiving guideline-directed medical heart failure (HF) therapy, patients with pulmonary hypertension associated with left heart disease (PH-LHD) experience higher mortality and hospitalization rates than the general HF population. AZD3427 is a functionally selective, long-acting mimetic of relaxin, a hormone that has the potential to induce vasodilation and prevent fibrosis. In a phase 1b study conducted in patients with HF, AZD3427 demonstrated a favourable safety and pharmacokinetic profile. To address the unmet medical need in patients with PH-LHD in the context of HF, AZD3427 is currently under development as a potential treatment option. METHODS AND RESULTS: The Re-PHIRE study is a phase 2b, randomized, double-blind, placebo-controlled, multicentre, dose-ranging study to evaluate the effect of AZD3427 on a broad range of PH-LHD phenotypes. In total, 220 patients will be randomized to four treatment groups to receive a subcutaneous injection of AZD3427 or placebo every 2 weeks for 24 weeks. The primary endpoint of the study is the change in pulmonary vascular resistance in patients treated with AZD3427 versus placebo after 24 weeks of treatment. Key secondary endpoints include changes in mean pulmonary arterial pressure, pulmonary artery wedge pressure, systemic vascular resistance, 6-min walking distance, N-terminal pro B-type natriuretic peptide levels, echocardiographic parameters, and health-related quality of life (assessed by the Kansas City Cardiomyopathy Questionnaire). CONCLUSIONS: Re-PHIRE is the first study of a relaxin mimetic in patients with PH-LHD. The insights gained from the Re-PHIRE study are expected to inform the further development of AZD3427 in the PH-LHD population, including identifying the most suitable pulmonary hypertension and HF phenotypes for treatment.
2nd Department of Internal Medicine University of Toyama Toyama Japan
2nd Department of Medicine Charles University and General University Hospital Prague Czechia
Canadian VIGOUR Centre University of Alberta Edmonton Canada
Department of Cardiology Zuyderland Medical Center Heerlen The Netherlands
Department of Internal Medicine 2 Division of Cardiology Medical University of Vienna Vienna Austria
Department of Medical Sciences Uppsala University Hospital Uppsala Sweden
Heart Failure and Transplantation Unit La Fe University and Polytechnic Hospital Valencia Spain
Heart Failure Program Yale School of Medicine New Haven Connecticut USA
Scottish National Advanced Heart Failure Service Golden Jubilee National Hospital Clydebank UK
The Heart Center Copenhagen University Hospital Rigshospitalet Copenhagen Denmark
University of Milan School of Medicine San Paolo University Hospital Milan Italy
Citace poskytuje Crossref.org
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