TAILOR-AHF: Randomized Trial Investigating a Tailored Diuretic Algorithm in Acute Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 556
- 试验地点
- 4
- 主要终点
- Hierarchical composite of all-cause mortality, heart failure events and delta quality of life at 90 days follow-up.
研究概览
简要总结
Acutely decompensated heart failure (ADHF) is highly prevalent and has a high (financial) burden on the health care system. Treatment often consists of the administration of IV decongestive agents. Adequate dosing is difficult due to varying diuretic resistance and inadequate parameters to evaluate the response. Urine sodium is a promising biomarker to evaluate the diuretic response. It is hypothesized that a tailored, urine sodium guided diuretic algorithm will result in faster and more complete decongestion and therefore lead to better survival (in terms of mortality and heart failure events) while being non-inferior in terms of safety (mainly regression of kidney function).
详细描述
Rationale: Acutely decompensated heart failure is a highly prevalent diagnosis with a high burden on resources and a high risk of mortality and re-hospitalization. The prescription of diuretics to relieve congestion has been the cornerstone of treatment for years, but evidence about diuretic response and adequate dosing is still lacking. Inadequate diuretic response (and insufficient decongestion) has a negative influence on outcome but is often not timely addressed. Urinary sodium (Ur-Na) is a promising biomarker in the prediction of diuretic response to the prescribed dose. It is hypothesized that an Ur-Na based, intensified algorithm can help tailor diuretics in an individual way, but sufficient evidence to support its implementation is lacking.
Objective: Investigate if a tailored diuretic algorithm based on Ur-Na has a positive effect on a primary endpoint of reduction in a combined endpoint of death, heart failure events and change in the Kansas City questionnaire total symptom score (KCCQ-TSS) versus standard clinical care in patients hospitalized with AHF, without imposing safety concerns (e.g. worsening renal function).
Study design: Prospective, Single-Blinded, Randomized, Blinded-endpoint trial
Study population: Patients admitted with acutely decompensated heart failure (diagnosed according to the 2021 ESC (European Society of Cardiology) guidelines) who are 18 year or older.
Intervention: Arm I: Tailored, Ur-Na based, intensified diuretic strategy; Arm II: Usual care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Age > 18 years;
- •HF (HFrEF, HFmrEF or HFpEF) diagnosed according to the 2021 HF Guidelines of the European Society of Cardiology [5];
- •Presentation with AHF meaning at least one symptom (dyspnea, orthopnea, or edema) and one sign (rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography) of AHF;
- •An elevated NT-proBNP >300pg/ml;
- •Requiring the need for iv diuretics.
排除标准
- •Terminal renal insufficiency defined as: dialysis patients or eGFR (estimated glomerular filtration rate) < 10 mL/min/1.73 m2;
- •Patients included in other investigational studies regarding heart failure.
- •Presentation with cardiogenic shock or respiratory insufficiency or another reason requiring admission to the intensive care unit upon admission (IC transfer later in the hospitalization is not an exclusion).
研究组 & 干预措施
Usual care
干预措施: Usual care (Other)
Tailored, Urine sodium guided, intensified diuretic strategy
干预措施: Urine sodium guided diuretic algorithm (Other)
结局指标
主要结局
Hierarchical composite of all-cause mortality, heart failure events and delta quality of life at 90 days follow-up.
时间窗: 90 days after inclusion
The primary endpoint is a hierarchical composite calculated using a win-ratio approach of: i) Mortality (all-cause) at 90 days after hospitalization; ii) Heart failure events at 90 days after hospitalization (1. a \>2 times increase in oral loop diuretic dose, 2. the need for iv administration of loop diuretics, 3. an emergency department visit or hospitalization for HF), wherein a single event or hospitalization will be sufficient to reach the combined endpoint; iii) Delta in quality of life measured using the Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS) from baseline to 90 days after hospitalization
次要结局
- Number of worsening heart failure events(90 days after inclusion)
- Delta weight(From date of randomization until date of hospital discharge (regarding initial hospitalisation at time of randomisation, assessed up to 90 days))
- Hospital length of stay(Number of days from hospitalization untill end of clinical treatment (not including days waiting for post-hospital care) or hospital discharge, whichever came first, assessed up to 90 days after randomization.)
- Worsening renal function(Baseline until 90 days follow-up)
- All-cause mortality and heart failure readmissions(14 days after inclusion)
- Delta NT-pro BNP(From admission to discharge and 90 days after hospitalisation)
- Successful decongestion(Day 3 after inclusion)
- Change in clinical congestion score(From date of randomization until date of hospital discharge (regarding initial hospitalisation at time of randomisation, assessed up to 90 days),)
- Quality of life (Kansas City Cardiomyopathy Questionnaire)(90 days after inclusion)
- Adverse (safety) events(90 days after inclusion)
- All-cause mortality and heart failure readmissions(6 months after inclusion)
- Chronic dialysis(90 days after inclusion)
- Days alive outside the hospital(90 days after inclusion)
- Time to first heart failure hospitalization and number of heart failure hospitalizations(90 days after inclusion)
- Number of outpatient visits(90 days after inclusion)
- Delta NT-pro BNP(From admission to discharge and 90 days after hospitalisation)
- Successful decongestion(Day 3 after inclusion)
- Change in clinical congestion score(From date of randomization until date of hospital discharge (regarding initial hospitalisation at time of randomisation, assessed up to 90 days),)
- Quality of life (Kansas City Cardiomyopathy Questionnaire)(90 days after inclusion)
- Adverse (safety) events(90 days after inclusion)
- All-cause mortality and heart failure readmissions(6 months after inclusion)
- Chronic dialysis(90 days after inclusion)
- Days alive outside the hospital(90 days after inclusion)
- Time to first heart failure hospitalization and number of heart failure hospitalizations(90 days after inclusion)
- Number of outpatient visits(90 days after inclusion)
- Number of worsening heart failure events(90 days after inclusion)
- Delta weight(From date of randomization until date of hospital discharge (regarding initial hospitalisation at time of randomisation, assessed up to 90 days))
- Hospital length of stay(Number of days from hospitalization untill end of clinical treatment (not including days waiting for post-hospital care) or hospital discharge, whichever came first, assessed up to 90 days after randomization.)
- Worsening renal function(Baseline until 90 days follow-up)