Ignite Creation Date:
2024-05-06 @ 7:30 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02546856
Status:
COMPLETED
Last Update Posted:
2020-12-16
First Post:
2015-05-18
Brief Title:
Safety and Effectiveness of Drug up Titration by Nurses Specialized in Heart Failure HF Patients
Sponsor:
Hospital Galdakao-Usansolo
Organization:
Hospital Galdakao-Usansolo
Study Overview
Official Title:
Safety and Effectiveness of Drug up Titration by Nurses Specialized in Heart Failure HF Patients
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETIFIC
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 CreatinineGlomerular Filtration Rate GFR Potassium K haemoglobin Blood Pressure BP Heart Rate HR mgdrug 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None