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

Hospital Galdakao-Usansolo

Status: Completed

Conditions: Heart Failure

Treatments: Other: Heart Failure (HF) cardiologist up-titration; Other: Heart Failure (HF) nurse up-titration

Study type: Interventional

Funder types: Other

Identifiers

NCT02546856

PI14/01208

Details and patient eligibility

About

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

Full description

No apply

Enrollment: 320 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with "de novo" heart Failure and LVEF <= 40% admitted in hospital, without contraindications for BB prescription with cardiologist up-titration prescription and without having achieved BB target dose previous discharge and signing informed consent.

Exclusion criteria

• Contraindications for BB.
• Living in a nursing home.
• Life expectancy < 6 months.
• Unable to self-care or mental disease without caregiver.
• Unable to weight
• Without phone
• Unable to go to clinic visit.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups

Heart Failure (HF) cardiologist up-titration

Active Comparator group

Description:

Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.

Treatment:

Other: Heart Failure (HF) cardiologist up-titration

HF nurse up-titration

Experimental group

Description:

Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.

Treatment:

Other: Heart Failure (HF) nurse up-titration