The Significance of the Vasopressin System of the Hemodynamics, Water Balance and Prognosis in Chronic Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Finn Gustafsson
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- 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
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Finn Gustafsson
Staff Cardiologist, PhD, DMSci
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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
Time Frame: 5 days
Secondary Outcomes
- 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)