NCT01748331Unknown不适用
The Significance of the Vasopressin System of the Hemodynamics, Water Balance and Prognosis in Chronic Heart Failure
Finn Gustafsson4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Change in plasma sodium from day 1 to day 4: - Normalization of plasma sodium or - A significant change in plasma sodium of a minimum of 5 mmol/L from baseline to day 4
研究概览
简要总结
The purpose of this study is to determine the effect of fluid restriction and the neurohormonal mechanisms in the development of hyponatremia in patients with congestive heart failure and hyponatremia. The hypothesis is that strict fluid restriction leads to a larger increase in plasma sodium than standard treatment in patients with decompensated heart failure associated with hyponatremia. A secondary hypothesis is that the neurohormonal change is greater in patients treated with strict fluid restriction versus standard treatment.
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
- •Left Ventricular Ejection Fraction (LVEF) < 40
- •At least two of the following signs of decompensated heart failure and fluid retention:
- •Weight gain > 2 kg
- •Pulmonal Congestion
- •Jugular vein congestion
- •Peripheral oedemas
- •Hepatic congestion with ascites
- •Radiographic signs of fluid retention
- •Increased diuretic dose
- •New York Heart Association (NYHA) class III-IV
- •Plasma sodium < 135 mmol/L
- •Symptomatic heart failure and treatment with relevant heart failure medications (beta-blocker, diuretic, digoxin, angiotensin-converting-enzyme inhibitor, angiotensin-II receptor antagonist, spironolactone, hydralazine and/or nitrates)for at least 1 month
- •Hospitalization for decompensated heart failure within the last 48 hours
- •Given informed consent
排除标准
- •Plasma sodium ≥ 135 mmol/L before randomization
- •Reduced kidney function (creatinine > 200 μmol/L)
- •Severe hematologic disease
- •Hypovolemic hyponatremia (volume depletion or dehydration)
- •Intolerability to large or fast changes in fluid volume assessed by the investigator
- •Plasma sodium < 120 mmol/L accompanied by neurologic symptoms
- •Symptomatic systolic blood pressure (supine systolic blood pressure < 90 mmHg)
- •Uncontrolled hypertension (systolic blood pressure > 180 mmHg)
- •Uncontrolled diabetes diabetes mellitus
- •Adrenal insufficiency
- •Acute myocardial infarction, sustained ventricular tachycardia or ventricular fibrillation within the last 30 days
- •Heart surgery within the last 60 days
- •Other severe heart disease: hypertrophic cardiomyopathy, severe heart valve disease, cardiac amyloidosis, active myocarditis, pericardial exudate which is hemodynamically significant
- •Left ventricular assist device (LVAD)
- •Planned revascularization procedure, electrophysiologic device implantation, mechanic left ventricular assist device, heart transplant or any other heart surgery procedures within the next 30 days
- •Cerebrovascular event within the last 6 months
- •Comorbidity with an expected survival < 6 months
- •Other reasons for hyponatremia: Primary syndrome of inappropriate antidiuretic hormone secretion (SIADH), primary polydipsia, head trauma, uncontrolled hypothyroidism, adrenal insufficiency or other known pharmacologically triggered hyponatremia which is reversible upon discontinuation of the drug, hyperglycemia (pseudohyponatremia), present abuse of alcohol
- •Pregnancy
- •Pregnant or fertile women who are not using safe contraception
- •Unwilling or unable to give informed consent
结局指标
主要结局
Change in plasma sodium from day 1 to day 4: - Normalization of plasma sodium or - A significant change in plasma sodium of a minimum of 5 mmol/L from baseline to day 4
时间窗: 5 days
次要结局
- Change in plasma vasopressin and copeptin(5 days)
- The correlation between hospitalization time and plasma sodium(5 days)
- Correlation between fluid restriction and change in kidney function(5 days)
- Patient assessment of fluid restriction(5 days)
- Number of days until clinical stability(5 days)
- Change in blood pressure, heart rate, weight and oedemas(5 days)
- Change in dyspnoea assessed by the patient(5 days)
- Patient compliance to fluid restriction(5 days)
研究者
Finn Gustafsson
Staff Cardiologist, PhD, DMSci
Rigshospitalet, Denmark
研究点 (4)
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