RT Journal Article
SR Electronic
T1 Ramipril and Cardiovascular Outcomes in Patients on Maintenance Hemodialysis
JF Clinical Journal of the American Society of Nephrology
JO CLIN J AM SOC NEPHROL
FD American Society of Nephrology
SP 575
OP 587
DO 10.2215/CJN.12940820
VO 16
IS 4
A1 Ruggenenti, Piero
A1 Podestà, Manuel Alfredo
A1 Trillini, Matias
A1 Perna, Annalisa
A1 Peracchi, Tobia
A1 Rubis, Nadia
A1 Villa, Davide
A1 Martinetti, Davide
A1 Cortinovis, Monica
A1 Ondei, Patrizia
A1 Condemi, Carmela Giuseppina
A1 Guastoni, Carlo Maria
A1 Meterangelis, Agnese
A1 Granata, Antonio
A1 Mambelli, Emanuele
A1 Pasquali, Sonia
A1 Genovesi, Simonetta
A1 Pieruzzi, Federico
A1 Bertoli, Silvio Volmer
A1 Del Rosso, Goffredo
A1 Garozzo, Maurizio
A1 Rigotti, Angelo
A1 Pozzi, Claudio
A1 David, Salvatore
A1 Daidone, Giuseppe
A1 Mingardi, Giulio
A1 Mosconi, Giovanni
A1 Galfré, Andrea
A1 Romei Longhena, Giorgio
A1 Pacitti, Alfonso
A1 Pani, Antonello
A1 Hidalgo Godoy, Jorge
A1 Anders, Hans-Joachim
A1 Remuzzi, Giuseppe
A1 on behalf of the ARCADIA Study Organization
YR 2021
UL http://cjasn.asnjournals.org/content/16/4/575.abstract
AB 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; P=0.80). Ramipril reduced cardiac mass index at 1 year of follow-up (between-group difference in change from baseline: −16.3 g/m2; 95% confidence interval, −29.4 to −3.1), but did not significantly affect the other secondary outcomes. Hypotensive episodes were more frequent in participants allocated to ramipril than controls (41% versus 12%). Twenty participants on ramipril and nine controls developed cancer, including six gastrointestinal malignancies on ramipril (four were fatal), compared with none in controls.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.