Spot Analysis of Natriuresis to Guide up- or Down-titration of Diuretic Therapy in Ambulatory Patients With Chronic Heart Failure (SAND-HF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in Clinical Congestion Score (Group 1)
研究概览
简要总结
Heart failure is a chronic condition that causes congestion and frequent hospitalizations. Diuretic doses are usually adjusted based on clinical judgment without an objective measure of response. This study will test the feasibility of using point-of-care urine sodium measurements to guide up-titration or down-titration of loop diuretics in ambulatory patients with heart failure.
Participants will be assigned to one of three groups based on congestion status. Groups 1 and 2 will be randomized 1:1 to natriuresis-guided therapy or standard care. Group 3 will be observational. The 90-day pilot trial will evaluate feasibility, clinical outcomes, and usability of a urine sodium-guided titration strategy.
详细描述
Heart failure is commonly associated with sodium retention and congestion. Loop diuretics are used to relieve congestion but are typically adjusted based on symptoms and clinical judgment. Spot urine sodium concentration is an objective measure of diuretic response that may help personalize treatment. A point-of-care urine sodium sensor provides rapid results and may support effective decongestion or safe reduction of diuretics when appropriate.
This prospective, two-center pilot study includes three clinical groups:
Group 1: Up-titration cohort Patients with clinical congestion or objective evidence of congestion. These participants will be randomized 1:1 to natriuresis-guided up-titration or standard care.
Group 2: Down-titration cohort Stable, euvolemic patients who may safely reduce diuretic therapy. These participants will be randomized 1:1 to natriuresis-guided down-titration or standard care.
Group 3: Observational cohort The first 100 screened patients who do not meet criteria for Groups 1 or 2. These participants will undergo baseline assessments and routine follow-up without intervention.
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
- 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
- •Age ≥18 years
- •Diagnosis of heart failure according to the Universal Definition
- •Use of loop diuretics
- •Residing in VCH or PHC regions
- •Group-specific inclusion:
- •Group 1: Congestion score ≥5 OR objective congestion; stable furosemide ≥1 week Group 2: NYHA I-II; congestion score <5; no recent HF hospitalization; stable furosemide ≥1 month Group 3: First 100 eligible patients not meeting criteria for Groups 1 or 2
排除标准
- •eGFR <20 mL/min/1.73m²
- •Renal replacement therapy
- •High-risk clinical status requiring hospitalization
- •Inability to consent or perform required urine sampling
研究组 & 干预措施
Group 1 - Natriuresis-Guided Up-Titration
Loop diuretic doses will be up-titrated based on post-diuretic urine sodium concentration measured using a point-of-care sensor. Insufficient natriuresis (<80 mmol/L) will prompt dose escalation according to a predefined algorithm.
干预措施: Natriuresis-Guided Up-Titration (Behavioral)
Group 1 Standard of Care (Up-Titration Control)
Participants will receive usual clinical management of diuretics at the discretion of their treating physician without access to urine sodium-guided titration.
干预措施: Standard care (Other)
Group 2 Natriuresis-Guided Down-Titration
Loop diuretic doses will be reduced based on urine sodium levels. If urine sodium ≥80 mmol/L, the current dose will be maintained; if <80 mmol/L, dose will be reduced according to a predefined algorithm. Re-titration criteria include symptomatic weight gain >2 kg in one week.
干预措施: Natriuresis-Guided Down-Titration (Behavioral)
Group 2 Standard Care (Down-Titration Control)
Participants will receive usual care without urine sodium-guided adjustments.
干预措施: Standard care (Other)
Group 3 Observational Cohort
Participants who do not meet inclusion criteria for Groups 1 or 2 will undergo baseline urine sodium assessment and routine clinical follow-up. No study-directed titration will occur.
干预措施: Observational Follow-up (Other)
结局指标
主要结局
Change in Clinical Congestion Score (Group 1)
时间窗: 90 Days
Change in clinical congestion score among Group 1 participants.
Successful Down-Titration of Loop Diuretics (Group 2)
时间窗: 90 Days
Proportion of Group 2 participants who maintain a reduced loop diuretic dose without needing up-titration during follow-up.
次要结局
- Dyspnea Visual Analogue Scale (VAS) Area Under the Curve(90 Days)
- Change in KCCQ-12 Score(90 Days)
- Change in NYHA Functional Class(Baseline, 30 days, 90 days)
- Signs of Volume Overload(Proportion of participants with clinical signs of volume overload.)
- Change in Body Weight(90 Days)
- Loop Diuretic Use and Dose(Baseline, 30 days, 90 days)
- Guideline-Directed Medical Therapy (GDMT) Use(90 days)
- NT-proBNP Concentration(90 days)
- Hemoconcentration(90 days)
- Change in Creatinine and BUN(90 days)
- Worsening Renal Function(90 days)
- Hypokalemia(90 Days)
- Urine Sodium ≥80 mmol/L (Group 1)(90 Days)
- Point-of-Care vs Laboratory Sodium Measurement Agreement(Baseline to 90 days)
- System Usability Scale(90 Days)
研究者
Nathaniel Hawkins
Clinical Associate Professor
Cardiology Research UBC