Clinical trial NCT02546856: Safety and Effectiveness of Drug up Titration by Nurses Specialized in Heart Failure (HF) Patients
Official title: Safety and Effectiveness of Drug up Titration by Nurses Specialized in Heart Failure (HF) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Up-titration
Nursing or Nurse
Heart Failure
Lead sponsor: Hospital Galdakao-Usansolo
Sponsor class: OTHER_GOV
Collaborators: name: Carlos III Health Institute
name: Basque Health Service
First posted: 2015-09-11
Enrollment: 320
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed description: No apply

Eligibility criteria: 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.

Primary outcomes:
measure: BB % Relative Dose (Mean) With Regard to Target Dose
timeFrame: 4 months
Secondary outcomes:
measure: Number of Participants With Worsening Renal Function (From Baseline to 4th Month)
timeFrame: 4 months
measure: Number of Participants With Potassium (K) ≥5.5 Meq/l (From Baseline to 4 Month)
timeFrame: 4 months
measure: Number of Participants With Symptomatic Hypotension (From Baseline to 4 Month)
timeFrame: 4 months
measure: Number of Participants With Heart Rate (HR) < 50 Beats Per Minute (From Baseline to 4 Month)
timeFrame: 4 months
measure: Number of Patients With Atrio Ventricular (AV) Block Due to Titration
timeFrame: 4 months
measure: Number of Patients With Worsening of Heart Failure Signs and Symptoms
timeFrame: 4 months
measure: Number of Patients With Admissions Due to Titration
timeFrame: 4 months
measure: Number of Patients: Mortality Due to Titration
timeFrame: 4 months
measure: Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment)
timeFrame: 4 months
measure: Change in % Left Ventricular Ejection Fraction
timeFrame: 6 months
measure: N-terminal Pro-B Type Natriuretic Peptide Improvement (Nt-proBNP)
timeFrame: 6 months
measure: 6 Minute Walking Test
timeFrame: 6 months
measure: Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV
timeFrame: 6 months
measure: Quality of Life: MLWHFQ
timeFrame: 6 months
measure: European Quality of Life Scale: EuroQol- 5 Dimension Index
timeFrame: 6 months
measure: Number of Patients With Admissions Due to Heart Failure (HF)
timeFrame: 6 months
measure: Number of Patients With Deaths
timeFrame: 6 months
measure: ACEI % Relative Dose (Mean) With Regard to Target Dose
timeFrame: 4 Months
measure: ARB % Relative Dose (Mean) With Regard to Target Dose
timeFrame: 4 months
measure: MRA % Relative Dose (Mean) With Regard to Target Dose
timeFrame: 4 months
Other outcomes:
Locations:
city: Usansolo
country: Spain
facility: Hospital de usansolo-Galdakao
state: Bizkaia
Study officials:
affiliation: Osakidetza-Servicio vasco de Salud
name: Maria Juana Oyanguren, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.