Hypertonic Saline Solution in Heart Failure

Study Overview
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Brief Summary
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Patients with decompensated heart failure have high rates of mortality and morbidity despite recent improvements in diagnosis and treatment. Some aspects of their presentation such as renal failure, hyponatremia and congestive phenomena have received special attention, as they are associated with worse prognosis. The infusion of hypertonic saline solution has been tested in different conditions of cardiovascular collapse. Current evidence indicates that the infusion of hypertonic solution in heart failure patients can provide clinical and haemodynamic improvement. The investigators are testing the hypothesis that the infusion of hypertonic solution in association with diuretics may prevent the occurrence of renal dysfunction in patients with decompensated heart failure.

Official Title
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Hypertonic Saline Solution in Decompensated Heart Failure

Conditions
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Heart Failure, Renal Failure, Hyponatremia

Intervention / Treatment
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* Drug: NaCl 7,5% (Hypertonic Saline Solution)
* Drug: NaCl 0,9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years old Heart failure according to Framingham criteria Episode of acute decompensation,with need of in-hospital treatment Presence of congestive phenomena Exclusion Criteria: Patient denial Left-ventricle ejection fraction over 0,4, as measure by transthoracic echocardiography Rheumatic disease Restrictive cardiomyopathy Alcohol abuse Chronic obstructive pulmonary disease Cancer Pulmonary embolism during the last 6 months Surgical procedures or acute illness during the last 30 days Chronic or acute infection Any other circumstance that may hamper patient prognosis for the next 6 months Serum creatine over 3.0mg/dL Serum potassium over 5.5 mEqs/L Any specific condition associated to the acute episode of decompensation, such as new onset cardiac arrhythmias, heart ischemia, infection, etc.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Group of patients that will receive hypertonic saline solution (NaCl 7,5%) | Drug: NaCl 7,5% (Hypertonic Saline Solution)<br>* Patients in the intervention arm will receive 100ml of NaCl 7,5, twice daily during 3 days<br>|
| Placebo Comparator: B<br>Group of patients that will receive placebo | Drug: NaCl 0,9%<br>* Patients in the placebo arm will receive 100ml of NaCl 0,9% twice daily during 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of renal disfunction |  | During hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of hyponatremia |  | During hospital admission | 
| Improvement of congestive phenomena |  | During hospital admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Renal failure, Hyponatremia