The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia

Study Overview
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Brief Summary
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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.

Official Title
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The Significance of the Vasopressin System of the Hemodynamics, Water Balance and Prognosis in Chronic Heart Failure

Conditions
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Heart Failure, Hyponatremia

Intervention / Treatment
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* Other: Fluid restriction


Participation Criteria
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Eligibility Criteria
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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 And 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 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 Anuria 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 Dementia Unwilling or unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Strict fluid restriction < 1 L/day<br>20 patients will be randomized to strict fluid restriction < 1 L/day | Other: Fluid restriction<br>* Patients will be randomized to strict fluid restriction < 1 L/day versus moderate fluid restriction < 2.5 L/day<br>|
| Other: Moderate fluid restriction < 2.5 L/day<br>20 patients will be randomized to moderate fluid restriction < 2.5 L/day | Other: Fluid restriction<br>* Patients will be randomized to strict fluid restriction < 1 L/day versus moderate fluid restriction < 2.5 L/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma vasopressin and copeptin |  | 5 days | 
| Change in blood pressure, heart rate, weight and oedemas |  | 5 days | 
| Change in dyspnoea assessed by the patient |  | 5 days | 
| Number of days until clinical stability |  | 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 | 
| Patient compliance to fluid restriction |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Hyponatremia, Fluid restriction