BIOmarker Based Diagnostic TOOLkit to Personalise Pharmacological Approaches in Congestive Heart Failure: the BIOTOOL-CHF Validation Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 1
研究概览
简要总结
By the re-analysis, in the BIOTOOL-CHF DISCO study, of a previously enrolled cohort of patients, a Biological Congestion Score (BCS) was newly developed. The BCS integrates four congestion-related biomarkers with key clinical variables. The BIOTOOL-CHF VALID trial is designed to prospectively evaluate whether a BCS-assisted strategy for diuretic management improves clinical outcomes and quality of life in patients with chronic Heart Failure (HF) compared with standard care.
详细描述
This prospective randomised study is part of a wider project that has been funded within the Horizon program by the call HORIZON-HLTH-2022-TOOL-11-01, project # 101095653, BIOTOOL-CHF. Herein the study will compare the outcomes of patients with chronic HF managed according to current usual clinical practice vs. patients in which therapy will be managed following the calculation of the BCS. In the BIOTOOL-CHF DISCO study, the BCS showed high accuracy in detecting congestion and better performance than clinical assessment in predicting outcomes, so it was hypothesized that, by providing a more accurate estimate of congestion in patients with chronic heart failure, the BCS may assist clinicians in managing diuretic therapy more accurately than the usual clinical assessment. The primary objective will be the comparison of standard-of-care management of chronic heart failure with a BCS-assisted strategy for guiding diuretic therapy, assessing the impact on a hierarchical composite clinical outcome at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Adult patients with symptomatic chronic heart failure diagnosed at least 3 months prior to randomization
- •Treatment with at least 40 mg of oral furosemide or equivalent at the time of enrolment to control symptoms
- •At least one of the following:
- •At discharge from hospitalization for heart failure
- •History of hospitalization for heart failure in the previous 3 months
- •History of treatment with intravenous diuretics or inotropes in ambulatory setting in the previous 3 months
- •B-type Natriuretic Peptide (BNP) > 400 pg/ml or N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 1000 pg/ml if in sinus rhythm or BNP > 800 pg/ml or NT-proBNP > 2000 pg/ml if in atrial fibrillation (AF) assessed within 4 weeks before enrolment
排除标准
- •Acute coronary syndrome or cerebrovascular accident in the previous 30 days
- •Acute heart failure requiring immediate hospitalization or intravenous therapy (acute pulmonary edema, cardiogenic shock, arrhythmic storm)
- •Clinical congestion score greater or equal to 5 at the time of randomization
- •Any cardiovascular intervention (cardiac surgery/coronary revascularization (Coronary Artery Bypass Grafting (CABG) or Percutaneous Coronary Intervention (PCI))/ Cardiac Resynchronization Therapy (CRT) implant, percutaneous treatment of valve disease, arrhythmias ablation) performed in the previous 3 months or planned in the following 3 months
- •Active myocarditis
- •Patients with any wearable or implantable device for congestion monitoring which is actively used to guide clinical practice
- •Patients with left ventricular assist device (LVAD)/ biventricular assist device (Bi-VAD) or heart transplantation
- •Severe stenotic valvular disease
- •Glomerular Filtration Rate (GFR) <15 ml/min (estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)) or dialysis (hemodialysis or peritoneal dialysis)
- •Liver cirrhosis with ascites
- •Significant cognitive impairment
- •Pregnancy or planned pregnancy during the study period
- •Active malignancy or severe hematological disorders
研究组 & 干预措施
Intervention Group
干预措施: Intervention: diuretic therapy guided by the Biological Congestion Score (BCS) using a predefined treatment nomogram (Other)
Control Group
结局指标
主要结局
未指定
次要结局
- Percent Change from Baseline in Bio-Adrenomedullin (Bio-ADM) Plasma Concentration(Baseline and 3 months)
- Number of Participants Receiving All Recommended GDMT Classes(3 months)