학술논문
Design of a multicentre randomized controlled trial to assess the safety and efficacy of dose titration by specialized nurses in patients with heart failure. ETIFIC study protocol.
Document Type
Academic Journal
Author
Oyanguren J; Department of Cardiology, Galdakao Hospital-Barrualde, Osakidetza-Basque Health Service, Bilbao, Spain.; García-Garrido L; Department of Cardiology, Girona University Hospital Dr. Josep Trueta, Girona, Spain.; Nebot Margalef M; Department Cardiology, Catalan Institute of Health, Bellvitge University Hospital, IDIBELL, Institute of Biomedical Research, Barcelona, Spain.; Lekuona I; Department of Cardiology, Galdakao Hospital-Barrualde, Osakidetza-Basque Health Service, Bilbao, Spain.; Comin-Colet J; Department of Cardiology, Instituto Hospital del Mar de Investigaciones Médicas (IMIM), Barcelona, Spain.; Manito N; Department Cardiology, Catalan Institute of Health, Bellvitge University Hospital, IDIBELL, Institute of Biomedical Research, Barcelona, Spain.; Roure J; Department of Cardiology, Girona University Hospital Dr. Josep Trueta, Girona, Spain.; Ruiz Rodriguez P; Department of Cardiology, Instituto Hospital del Mar de Investigaciones Médicas (IMIM), Barcelona, Spain.; Enjuanes C; Department of Cardiology, Instituto Hospital del Mar de Investigaciones Médicas (IMIM), Barcelona, Spain.; Latorre P; Primary Care Research Unit, Bizkaia, Bilbao, Spain.; Torcal Laguna J; Primary Care Research Unit, Bizkaia, Bilbao, Spain.; García-Gutiérrez S; Galdakao Hospital Research Unit, Galdakao, Spain.
Source
Publisher: John Wiley & Sons Ltd on behalf of the European Society of Cardiology Country of Publication: England NLM ID: 101669191 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2055-5822 (Electronic) Linking ISSN: 20555822 NLM ISO Abbreviation: ESC Heart Fail Subsets: MEDLINE
Subject
Language
English
Abstract
Aims: Heart failure (HF) is associated with many hospital admissions and relatively high mortality, rates decreasing with administration of beta-blockers (BBs), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blockers, and mineralocorticoid receptor antagonists. The effect is dose dependent, suboptimal doses being common in clinical practice. The 2012 European guidelines recommend close monitoring and dose titration by HF nurses. Our main aim is to compare BB doses achieved by patients after 4 months in intervention (HF nurse-managed) and control (cardiologist-managed) groups. Secondary aims include comparing doses of the other aforementioned drugs achieved after 4 months, adverse events, and outcomes at 6 months in the two groups.
Methods: We have designed a multicentre (20 hospitals) non-inferiority randomized controlled trial, including patients with new-onset HF, left ventricular ejection fraction ≤40%, and New York Heart Association class II-III, with no contraindications to BBs. We will also conduct qualitative analysis to explore potential barriers to and facilitators of dose titration by HF nurses. In the intervention group, HF nurses will implement titration as prescribed by cardiologists, following a protocol. In controls, cardiologists will both prescribe and titrate doses. The study variables are doses of each of the drugs after 4 months relative to the target dose (%), New York Heart Association class, left ventricular ejection fraction, N-terminal pro B-type natriuretic peptide levels, 6 min walk distance, comorbidities, renal function, readmissions, mortality, quality of life, and psychosocial characteristics.
Conclusions: The trial seeks to assess whether titration by HF nurses of drugs recommended in practice guidelines is safe and not inferior to direct management by cardiologists. The results could have an impact on clinical practice.
(© 2017 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.)
Methods: We have designed a multicentre (20 hospitals) non-inferiority randomized controlled trial, including patients with new-onset HF, left ventricular ejection fraction ≤40%, and New York Heart Association class II-III, with no contraindications to BBs. We will also conduct qualitative analysis to explore potential barriers to and facilitators of dose titration by HF nurses. In the intervention group, HF nurses will implement titration as prescribed by cardiologists, following a protocol. In controls, cardiologists will both prescribe and titrate doses. The study variables are doses of each of the drugs after 4 months relative to the target dose (%), New York Heart Association class, left ventricular ejection fraction, N-terminal pro B-type natriuretic peptide levels, 6 min walk distance, comorbidities, renal function, readmissions, mortality, quality of life, and psychosocial characteristics.
Conclusions: The trial seeks to assess whether titration by HF nurses of drugs recommended in practice guidelines is safe and not inferior to direct management by cardiologists. The results could have an impact on clinical practice.
(© 2017 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.)