NCT02546856

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 27, 2020

Completed
Last Updated

December 16, 2020

Status Verified

November 1, 2020

Enrollment Period

3.6 years

First QC Date

May 18, 2015

Results QC Date

September 15, 2020

Last Update Submit

November 26, 2020

Conditions

Heart Failure

Keywords

Up-titrationNursing or NurseHeart Failure

Outcome Measures

Primary Outcomes (1)

  • BB % Relative Dose (Mean) With Regard to Target Dose

    BB mean Relative dose is the mean dose of betablockers achieved 4 months after starting titration, relative to target dose ( %) , which is the target dose of european heart failure guidelines for BB.

    4 months

Secondary Outcomes (20)

  • Number of Participants With Worsening Renal Function (From Baseline to 4th Month)

    4 months

  • Number of Participants With Potassium (K) ≥5.5 Meq/l (From Baseline to 4 Month)

    4 months

  • Number of Participants With Symptomatic Hypotension (From Baseline to 4 Month)

    4 months

  • Number of Participants With Heart Rate (HR) < 50 Beats Per Minute (From Baseline to 4 Month)

    4 months

  • Number of Patients With Atrio Ventricular (AV) Block Due to Titration

    4 months

  • +15 more secondary outcomes

Study Arms (2)

Heart Failure (HF) cardiologist up-titration

ACTIVE COMPARATOR

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

Other: Heart Failure (HF) cardiologist up-titration

HF nurse up-titration

EXPERIMENTAL

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

Other: Heart Failure (HF) nurse up-titration

Interventions

Heart Failure (HF) nurse up-titrationOTHER

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.

HF nurse up-titration
Heart Failure (HF) cardiologist up-titrationOTHER

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.

Heart Failure (HF) cardiologist up-titration

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de usansolo-Galdakao

Usansolo, Bizkaia, 48960, Spain

Location

Related Publications (3)

  • 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.

    PMID: 29154427BACKGROUND

  • 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.

    PMID: 32591295RESULT

  • 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.

    PMID: 34903479DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Limitations and Caveats

the implementation of ETIFIC in a single country; its recruitment characteristics, inclusion of de novo HF patients exclusively, relatively young patients and the low percentage of women and patients with ischemic heart disease.

Results Point of Contact

Title
Juana Oyanguren, Nursing graduate, Master in Heart Failure, CV Pathology and Thrombosis Specialist
Organization
Servicio de Cardiologıa, Hospital Universitario Galdakao-Usansolo, OSI Barrualde-Galdakao-Osakidetza, Servicio Vasco de Salud, Galdakao, Bizkaia, Spain .BIOCRUCES, Instituto de Investigacion Sanitaria, Bizkaia, Spain
juanaoy@hotmail.com
34 656780945

Study Officials

  • Maria Juana Oyanguren, Nurse

    Osakidetza-Servicio vasco de Salud

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Heart Failure Nurse

Study Record Dates

First Submitted

May 18, 2015

First Posted

September 11, 2015

Study Start

March 1, 2015

Primary Completion

October 1, 2018

Study Completion

April 1, 2019

Last Updated

December 16, 2020

Results First Posted

November 27, 2020

Record last verified: 2020-11

Locations

ES(1)