Ramipril and Cardiovascular Outcomes in Patients on Maintenance Hemodialysis: The ARCADIA Multicenter Randomized Controlled Trial.
ACE inhibitors
Ramipril
cardiovascular events
hemodialysis
renin angiotensin system
Journal
Clinical journal of the American Society of Nephrology : CJASN
ISSN: 1555-905X
Titre abrégé: Clin J Am Soc Nephrol
Pays: United States
ID NLM: 101271570
Informations de publication
Date de publication:
07 04 2021
07 04 2021
Historique:
received:
07
08
2020
accepted:
15
02
2021
pubmed:
31
3
2021
medline:
1
1
2022
entrez:
30
3
2021
Statut:
ppublish
Résumé
Renin-angiotensin system (RAS) inhibitors reduce cardiovascular morbidity and mortality in patients with CKD. We evaluated the cardioprotective effects of the angiotensin-converting enzyme inhibitor ramipril in patients on maintenance hemodialysis. In this phase 3, prospective, randomized, open-label, blinded end point, parallel, multicenter trial, we recruited patients on maintenance hemodialysis with hypertension and/or left ventricular hypertrophy from 28 Italian centers. Between July 2009 and February 2014, 140 participants were randomized to ramipril (1.25-10 mg/d) and 129 participants were allocated to non-RAS inhibition therapy, both titrated up to the maximally tolerated dose to achieve predefined target BP values. The primary efficacy end point was a composite of cardiovascular death, myocardial infarction, or stroke. Secondary end points included the single components of the primary end point, new-onset or recurrence of atrial fibrillation, hospitalizations for symptomatic fluid overload, thrombosis or stenosis of the arteriovenous fistula, and changes in cardiac mass index. All outcomes were evaluated up to 42 months after randomization. At comparable BP control, 23 participants on ramipril (16%) and 24 on non-RAS inhibitor therapy (19%) reached the primary composite end point (hazard ratio, 0.93; 95% confidence interval, 0.52 to 1.64; Ramipril did not reduce the risk of major cardiovascular events in patients on maintenance hemodialysis. ARCADIA, NCT00985322 and European Union Drug Regulating Authorities Clinical Trials Database number 2008-003529-17.
Sections du résumé
BACKGROUND AND OBJECTIVES
Renin-angiotensin system (RAS) inhibitors reduce cardiovascular morbidity and mortality in patients with CKD. We evaluated the cardioprotective effects of the angiotensin-converting enzyme inhibitor ramipril in patients on maintenance hemodialysis.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS
In this phase 3, prospective, randomized, open-label, blinded end point, parallel, multicenter trial, we recruited patients on maintenance hemodialysis with hypertension and/or left ventricular hypertrophy from 28 Italian centers. Between July 2009 and February 2014, 140 participants were randomized to ramipril (1.25-10 mg/d) and 129 participants were allocated to non-RAS inhibition therapy, both titrated up to the maximally tolerated dose to achieve predefined target BP values. The primary efficacy end point was a composite of cardiovascular death, myocardial infarction, or stroke. Secondary end points included the single components of the primary end point, new-onset or recurrence of atrial fibrillation, hospitalizations for symptomatic fluid overload, thrombosis or stenosis of the arteriovenous fistula, and changes in cardiac mass index. All outcomes were evaluated up to 42 months after randomization.
RESULTS
At comparable BP control, 23 participants on ramipril (16%) and 24 on non-RAS inhibitor therapy (19%) reached the primary composite end point (hazard ratio, 0.93; 95% confidence interval, 0.52 to 1.64;
CONCLUSIONS
Ramipril did not reduce the risk of major cardiovascular events in patients on maintenance hemodialysis.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER
ARCADIA, NCT00985322 and European Union Drug Regulating Authorities Clinical Trials Database number 2008-003529-17.
Identifiants
pubmed: 33782036
pii: 01277230-202104000-00013
doi: 10.2215/CJN.12940820
pmc: PMC8092055
doi:
Substances chimiques
Angiotensin-Converting Enzyme Inhibitors
0
Ramipril
L35JN3I7SJ
Banques de données
ClinicalTrials.gov
['NCT00985322']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
575-587Investigateurs
Giuseppe Remuzzi
(G)
Patrizia Ondei
(P)
Carmela Giuseppina Condemi
(CG)
Stefano Rota
(S)
Carlo Maria Guastoni
(CM)
Nicoletta Bellotti
(N)
Anna Lisa Neri
(AL)
Valentina Martina
(V)
Barbara Gidaro
(B)
Antonia Stasi
(A)
Agnese Meterangelis
(A)
Salvatrice Tamburello
(S)
Maria Alessandra Riva
(MA)
Emanuela Cortinovis
(E)
Antonio Granata
(A)
Benedetta Salamone
(B)
Elena Mancini
(E)
Elisa Persici
(E)
Elena Sestigiani
(E)
Emanuele Mambelli
(E)
Sonia Pasquali
(S)
Achiropita Bovino
(A)
Andrea Stella
(A)
Simonetta Genovesi
(S)
Paolo Fabbrini
(P)
Erika Casiraghi
(E)
Silvio Volmer Bertoli
(SV)
Silvia Tedoldi
(S)
Giada Bigatti
(G)
Goffredo Del Rosso
(G)
Rosella Malandra
(R)
Dario Sassone
(D)
Maurizio Garozzo
(M)
Giovanni Giorgio Battaglia
(GG)
Angelo Rigotti
(A)
Davide Cerretani
(D)
Stefano Bini
(S)
Claudio Pozzi
(C)
Enzo Corghi
(E)
Salvatore David
(S)
Chiara Cantarelli
(C)
Valentina Blanco
(V)
Giuseppe Daidone
(G)
Gianni Ottaviano
(G)
Giulio Mingardi
(G)
Stefano Rota
(S)
Giovanna Franca Ledda
(GF)
Giovanni Mosconi
(G)
Loretta Zambianchi
(L)
Piergiorgio Bolasco
(P)
Andrea Galfrè
(A)
Stefano Murtas
(S)
Ugo Teatini
(U)
Giorgio Romei Longhena
(GR)
Alfonso Pacitti
(A)
Paola Inguaggiato
(P)
Antonello Pani
(A)
Giuliana Dessì
(G)
Francesco Scolari
(F)
Sergio Bove
(S)
Mario Cozzolino
(M)
Meri Pedone
(M)
Marco Farina
(M)
Francesco Barbisoni
(F)
Renzo Scanziani
(R)
Gennaro Santorelli
(G)
Donatella Spotti
(D)
Maria Teresa Sciarrone Alibrandi
(MTS)
Ferruccio Conte
(F)
Francesca Stefani
(F)
Salvatore Badalamenti
(S)
Rossella Valentino
(R)
Nadia Rubis
(N)
Wally Calini
(W)
Olimpia Diadei
(O)
Alessandro Villa
(A)
Davide Villa
(D)
Davide Martinetti
(D)
Sergio Carminati
(S)
Giovanni Antonio Giuliano
(GA)
Annalisa Perna
(A)
Francesco Peraro
(F)
Tobia Peracchi
(T)
Piero Ruggenenti
(P)
Matias Trillini
(M)
Manuel Alfredo Podestà
(MA)
Paola Boccardo
(P)
Sara Peracchi
(S)
Esteban Porrini
(E)
Ettore Sabadini
(E)
Francesco Peraro
(F)
Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2021 by the American Society of Nephrology.
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