Safety and Effectiveness of Drug up Titration by Nurses Specialized in Heart Failure (HF) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- BB % Relative Dose (Mean) With Regard to Target Dose
研究概览
简要总结
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
详细描述
No apply
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
BB % Relative Dose (Mean) With Regard to Target Dose
时间窗: 4 months
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.
次要结局
- 6 Minute Walking Test(6 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)
- MRA % Relative Dose (Mean) With Regard to Target Dose(4 months)
- 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 Patients With Atrio Ventricular (AV) Block Due to Titration(4 months)
- Number of Patients: Mortality Due to Titration(4 months)
- Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV(6 months)
- Number of Patients With Worsening of Heart Failure Signs and Symptoms(4 months)
- Number of Patients With Admissions Due to Titration(4 months)
- Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment)(4 months)
- Change in % Left Ventricular Ejection Fraction(6 months)
- Quality of Life: MLWHFQ(6 months)
- Number of Patients With Admissions Due to Heart Failure (HF)(6 months)
- N-terminal Pro-B Type Natriuretic Peptide Improvement (Nt-proBNP)(6 months)
- Number of Patients With Deaths(6 months)
- ACEI % Relative Dose (Mean) With Regard to Target Dose(4 Months)
- ARB % Relative Dose (Mean) With Regard to Target Dose(4 months)
- European Quality of Life Scale: EuroQol- 5 Dimension Index(6 months)
研究者
Maria Juana Oyanguren Artola
Heart Failure Nurse
Hospital Galdakao-Usansolo