Quantifying Interstitial and Intravascular Fluid Accumulation by Ultrasound Following Temporary Suspension of Loop Diuretics in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Differences in ultrasound markers or congestion following continuation or suspension of diuretics for 48 hours.
研究概览
简要总结
The investigators will determine the feasibility of identifying and quantifying changes in interstitial and intravascular congestion by imaging in participants with heart failure. The investigators will either continue or temporarily suspend both loop diuretics and mineralo-corticoid antagonists (MRA) for 48 hours in participants with heart failure that is both stable and mild and compare measurements of interstitial (B-lines) and intra-vascular fluids (IVC and JV diameter and renal venous flow) by ultrasound and, in a subset of participants without contra-indications, by cardiac MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of heart failure
- •Plasma NT-proBNP >125ng/L or BNP >35 ng/l
- •Left ventricular ejection fraction (LVEF) <50% on prior imaging test
- •Treated routinely with a daily dose of loop diuretic
- •Receiving other guideline-indicated therapy for heart failure
- •Willing to sign the informed consent form
- •Greater than 18 years of age
排除标准
- •Chronic Kidney Disease Stage 4 or worse (eGFR <30 mL/min/1.73 m²)
- •Atrial fibrillation
- •Significant valve disease (investigators opinion)
- •Breathlessness or chest pain at rest or minor exertion
- •Patients unable to lie flat
- •Patients deemed too unstable to miss treatment with diuretics for 48 hours
- •Patients taking part in another interventional trial
- •Any other concomitant condition that in the opinion of the investigator would not allow a safe participation in the study (ie:-pregnancy, significant frailty)
- •Patients unwilling or unable to consent
- •For patients willing to undergo MRI; contraindication to MRI including claustrophobia, metalworkers, and intra-orbital or intracranial metal (eg:- stents), and non-MRI compliant device.
结局指标
主要结局
Differences in ultrasound markers or congestion following continuation or suspension of diuretics for 48 hours.
时间窗: at baseline
Differences in interstitial (B-lines) and intravascular (IVC and JV diameter, and renal venous flow) congestion by ultrasound in patients with heart failure following continuation or suspension of diuretics for 48 hours.
次要结局
- The acute variation in interstitial and intravascular congestion on imaging tests following administration of diuretics.(up to 3 hours)
- The acute variation in biomarkers of congestion, inflammation and myocardial injury following administration of diuretics.(at 3 hours)