A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,415
- 试验地点
- 189
- 主要终点
- Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose
研究概览
简要总结
This low interventional study, whose unique intervention was to measure the blood level of a biomarker called NT-proBNP in chronic heart failure patients daily followed-up by Primary Care Physicians (PCPs) in Europe, assessed if the cardiologist referral guided by NT-proBNP measurement in patients who were currently judged by PCPs as being stable, would lead to optimization of HF treatment, defined in adherence to treatment recommendations of the current European Society of Cardiology guidelines for the treatment of heart failure.
详细描述
In the majority of European countries, the primary management of chronic heart failure patients was performed by General Practitioners in collaboration with cardiologists (specialists). Previous studies had shown that many patients suffering from CHF do not receive optimal pharmacological and/or device treatment for their disease. An increase in natriuretic peptides (BNP, NT-proBNP) was associated with increased risk of cardiovascular events in heart failure patients. The purpose of the present study was to assess if a referral of clinical stable chronic heart failure patients with reduced ventricular ejection fraction (EF < or = 40%) and NT-proBNP level > or = 600 pg/mL to a specialist (cardiologist) led to treatment optimization, defined as adherence to the treatment recommendations according to the European Society of Cardiology (ESC) guidelines. In addition, data obtained in this study was used to describe demographic, clinical (including NT-proBNP levels) and treatment characteristics of CHF patients who were managed in the primary care setting across Europe..
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent and accept study procedures and time schedule.
- •Age ≥ 18 years.
- •Patients suffering from chronic heart failure (the heart failure diagnosis must have been made or confirmed by a cardiologist and/or hospital physician at any time in the patient's medical history).
- •Patients with reduced ejection fraction (≤ 40%) as confirmed at any time point in the patient's medical history.
排除标准
- •Use of investigational drugs either within 5 half-lives of enrollment, or within 30 days, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
- •Major surgery in the last 3 months prior to baseline or planned major surgery or cardiac intervention during the study.
- •Cancer or other significant co-morbidities implying that the patient's condition is unstable.
- •Comorbidities that can be associated with elevated natriuretic peptide (NP) levels: renal insufficiency, (eGFR < 25 ml/min/1.73 m² calculated according to MDRD formula), recent (less than 3 months) cerebral trauma or recent (less than 3 months) cerebrovascular incident, novel diagnosis or acute exacerbation of COPD within the last 3 months.
- •Patients who are primarily managed and regularly followed-up by a cardiologist for their HF
- •Highly frail patients whose estimated lifespan due to comorbidities by the judgement of the investigator is less than 6 months.
结局指标
主要结局
Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose
时间窗: Month 6
Assessment of patients' adherence at Visit 2, for patients who were already adherent at Visit 1, and those who were not adherent at Visit 1, for both drug type and drug type and dose. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF \> 35% at visit 1. Drug type \& dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose.
Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist)
时间窗: Baseline (Visit 1)
Assessment of treatment regimen with respect to ESC guideline adherence at Visit 1 before referral to cardiologist. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF \> 35% at visit 1. Drug type \& dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose.
次要结局
- Number of Patients by Cardiologist Prescription Practice Per Country/Region(6 months)
- Number of Patients From Different Geographical Regions(Baseline (visit 1))
- Mean Dose of Previously Taken and Current Use of Concomitant Medications(Baseline (Visit 1), 6 months, 10 months)
- Duration of Treatment With Device Type(Baseline (Visit 1))
- Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months)(Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3))
- Number of Patients at Different Educational Level(Baseline (Visit 1))
- Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2(6 months (Visit 2))
- Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline(10 months)
- Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities(Baseline (Visit 1))
- Duration of Previously Taken and Currently Use of Most Common Non-Heart Failure Concomitant Compounds(Baseline (Visit 1))
- Number of Patients by Primary Care Physicians' Prescription Practice Per Country/Region(Baseline (Visit 1))
- Duration of Heart Failure(Baseline (Visit 1))
- Number of Patients With Current Use of Concomitant Compound(Baseline (Visit 1))
- Percentages of Clinically Stable Patients(Baseline (Visit 1))
- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months)(Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3))
- Number of Patients in Different Employment Status(Baseline (Visit 1))
- Number of Patients With Smoking Status(Baseline (Visit 1))
- Number of Heart Failure (HF) Treatment Combinations(Baseline (Visit 1))
- Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics(6 months)
- Number of Patients With Different NT-proBNP Level Categories(One measurement in all consecutive patients at baseline (Visit 1))
- Number of Patients in Different Living Conditions(Baseline (Visit 1))
- Number of Patients With Health Insurance Status(Baseline (Visit 1))
- Number of Patients Per Primary Etiology of Heart Failure(Baseline (Visit 1))
- Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study(Baseline (Visit 1), 6 months, 10 months)