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

NCT ID: NCT02546856

Last Updated: 2020-12-16

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-04-01

Brief Summary

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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

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No apply

Conditions

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Heart Failure

Keywords

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Up-titration Nursing or Nurse Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Heart Failure (HF) cardiologist up-titration

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

Group Type ACTIVE_COMPARATOR

Heart Failure (HF) cardiologist up-titration

Intervention Type OTHER

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.

HF nurse up-titration

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

Group Type EXPERIMENTAL

Heart Failure (HF) nurse up-titration

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carlos III Health Institute

OTHER_GOV

Sponsor Role collaborator

Basque Health Service

OTHER_GOV

Sponsor Role collaborator

Hospital Galdakao-Usansolo

OTHER_GOV

Sponsor Role lead

Responsible Party

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Maria Juana Oyanguren Artola

Heart Failure Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Juana Oyanguren, Nurse

Role: PRINCIPAL_INVESTIGATOR

Osakidetza-Servicio vasco de Salud

Locations

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Hospital de usansolo-Galdakao

Usansolo, Bizkaia, Spain

Site Status

Countries

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Spain

References

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Oyanguren J, Garcia-Garrido L, Nebot Margalef M, Lekuona I, Comin-Colet J, Manito N, Roure J, Ruiz Rodriguez P, Enjuanes C, Latorre P, Torcal Laguna J, Garcia-Gutierrez S; ETIFIC7 research group. 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. ESC Heart Fail. 2017 Nov;4(4):507-519. doi: 10.1002/ehf2.12152. Epub 2017 Apr 3.

Reference Type BACKGROUND
PMID: 29154427 (View on PubMed)

Oyanguren J, Garcia-Garrido L, Nebot-Margalef M, Latorre-Garcia P, Torcal-Laguna J, Comin-Colet J, Roure J, Gonzalez-Costello J, Manito N, Garcia-Pinilla JM, Sanchez-Paule Y, Varela-Roman A, Moure M, Segovia-Cubero J, Soria T, Arana-Arri E, Lekuona I; Steering Committee on behalf of the ETIFIC research team group. Noninferiority of heart failure nurse titration versus heart failure cardiologist titration. ETIFIC multicenter randomized trial. Rev Esp Cardiol (Engl Ed). 2021 Jun;74(6):533-543. doi: 10.1016/j.rec.2020.04.016. Epub 2020 Jun 24. English, Spanish.

Reference Type RESULT
PMID: 32591295 (View on PubMed)

Oyanguren J, Diaz-Molina B, Lekuona I, Gonzalez-Costello J, Lopez-Fernandez S, Garcia-Pinilla JM, Garcia-Garrido L, Lopez-Moyano G, Manito N, Cobo-Marcos M, Nebot-Margalef M, Latorre-Garcia P, Arana-Arri E, Perez-Fernandez S, Torcal-Laguna J; ETIFIC research team group. Gender differences in drug titration among heart failure patients with reduced ejection fraction in the ETIFIC trial. Rev Esp Cardiol (Engl Ed). 2022 Aug;75(8):636-648. doi: 10.1016/j.rec.2021.11.002. Epub 2021 Dec 10. English, Spanish.

Reference Type DERIVED
PMID: 34903479 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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PI14/01208

Identifier Type: -

Identifier Source: org_study_id