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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
- Source :
- ESC Heart Failure. 4:507-519
- Publication Year :
- 2017
- Publisher :
- Wiley, 2017.
-
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.
- Subjects :
- medicine.medical_specialty
Ejection fraction
New York Heart Association Class
business.industry
Renal function
030204 cardiovascular system & hematology
medicine.disease
law.invention
03 medical and health sciences
0302 clinical medicine
Quality of life
Randomized controlled trial
law
Heart failure
Emergency medicine
medicine
030212 general & internal medicine
Cardiology and Cardiovascular Medicine
Intensive care medicine
business
Adverse effect
Psychosocial
Subjects
Details
- ISSN :
- 20555822
- Volume :
- 4
- Database :
- OpenAIRE
- Journal :
- ESC Heart Failure
- Accession number :
- edsair.doi...........945d3d71c8e60d3de55f68f92128b55e