Impact of Nitroglycerin-induced Vasodilation on Stroke Volume and Diuretic Response in Acute Heart Failure: A Protocol for a Mechanistic Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Stroke volume
研究概览
简要总结
This study aims to understand how nitroglycerin affects patients with acute heart failure, a condition where the heart struggles to pump blood effectively, leading to fluid buildup and breathing difficulties. Nitroglycerin relaxes blood vessels to ease the heart's workload and may help reduce fluid buildup. The investigators hypothesize that nitroglycerin can increase blood flow from the heart and promote urine production, which may reduce congestion in AHF patients. By studying heart function, blood volume, and fluid levels during treatment, the goal is to identify which patients may benefit most from nitroglycerin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Clinical diagnosis of AHF requiring hospitalization
- •Systolic blood pressure ≥85 mmHg
- •Echocardiographic signs of cardiac dysfunction, by at least one of
- •Left ventricular ejection fraction ≤45%
- •Abnormal left ventricular filling with dilatation of the left atrium
- •Elevated filling pressures (systolic pulmonary artery pressure>30, dilated vena cava inferior or E/é>10)
- •Significant left-sided heart valve disease
排除标准
- •Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with heart rate > 180 or < 40 bpm.
- •Retinopathy or intraocular lens implantation (contraindication to Valsalva maneuver)
- •Recent myocardial infarction or thromboembolic events.
- •Intake of sildenafil or vardenafil withing 24 h and tadalafil within 48 h.
- •Absolute contraindication for vasodilation using nitroglycerin as assessed by treating physician
- •Intravenous administration of furosemide within 2 hours of baseline measurements
研究组 & 干预措施
Nitroglycerin
Infusion of intravenous nitroglycerin titrated towards a vasodilatory state which we predefined as a 20-30% decrease in mean arterial pressure (MAP) for 1.5 hours followed by a phase of 1.5 hours with no vasodilation.
干预措施: Nitroglycerin (NTG) (Drug)
结局指标
主要结局
Stroke volume
时间窗: From initiation of nitroglycerin infusion at time zero until study termination at 180 minutes.
Change in stroke volume (obtained from LiDCO) from baseline through vasodilation period.
次要结局
- Cumulated urinary output (mL)(From time zero until study termination at 180 minutes.)
- Mean arterial blood pressure(From time zero throughout the study period until termination at time 180 minutes.)
- Heart rate(From time zero throughout the study period until termination at time 180 minutes.)
- Cardiac output(At baseline and at timepoints 90 minutes and 180 minutes.)
- Peripheral perfusion index(From time zero throughout the study period until termination at time 180 minutes.)
- Systemic vascular resistance(From time zero throughout the study period until termination at time 180 minutes.)
研究者
Frederik Lau
Medical Doctor
Copenhagen University Hospital, Hvidovre