NCT02546856

Safety and Effectiveness of Drug up Titration by Nurses Specialized in Heart Failure (HF) Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Hospital Galdakao-Usansolo · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Introduction: Heart Failure (HF) generates multiple hospital admissions and mortality, which are reduced with the administration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) drugs (Level of Evidence A). The effect is dose-dependent. Nevertheless, dosages are suboptimal. European Guidelines 2012 recommend close monitoring and up-titration of drugs by HF nurses. Trials are needed to evaluate their effectiveness and safety. Objective: To compare doses achieved by patients of BB, ACEI, ARB II and MRA in 4 months ( % relative to target doses) in the intervention group (HF nurse) and in the control group ( cardiologist), adverse events, Left Ventricular Ejection Fraction (LVEF), New York Heart Association (NYHA), 6 min. walking test, quality of life, Nt-proBNP, readmissions and mortality. Hypothesis: Non-inferiority. Design: Multicenter randomized controlled trial. New ("de novo") HF patients with LVEF ≤ 40%, NYHA II-III, without contraindications to BB of 17 Spanish hospitals will be included. Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration. In the control group doses are decided by the cardiologist clinical support and education being provided by nurses. Variables: age, sex, education, psycho-social level, Cardio Vascular Risk Factors (CVRF), NYHA, LVEF, ischemic cardiopathy., N-terminal pro B-type natriuretic peptide (Nt-proBNP), 6min. walking test, Creatinine/Glomerular Filtration Rate (GFR), Potassium (K), haemoglobin, Blood Pressure (BP), Heart Rate (HR), mg./drug, European Heart Failure Self-Care Behaviour Scale (EHFScBS), Minnesota Living with Heart Failure questionnaire (MLHFQ), European Quality of life Scale (EQ-5D). Expected Results: If our hypothesis were confirmed, evidence would be provided on the effectiveness of this healthcare management, that could be economically evaluated in future studies. A qualitative study also will be undertaken to explore barriers and facilitators to implementation

Detailed description

No apply

Conditions

• Heart Failure

Interventions

Type	Name	Description
OTHER	Heart Failure (HF) nurse up-titration	Up-titration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure "De Novo" patients with Left Ventricular Ejection Fraction (LVEF)≤ 40%, following a protocol based on 2012 European Society of Cardiology (ESC) Heart Failure (HF) guidelines with cardiologist prescription and support.
OTHER	Heart Failure (HF) cardiologist up-titration	Up-titration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure "De Novo" patients with Left Ventricular Ejection Fraction (LVEF)≤ 40%, following a protocol based on 2012 European Society of Cardiology (ESC) Heart Failure (HF) guidelines. Drugs are prescribed and titrated by the cardiologist.

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-10-01
• Completion: 2019-04-01
• First posted: 2015-09-11
• Last updated: 2020-12-16
• Results posted: 2020-11-27

Locations

1 site across 1 country: Spain