Hypertonic Saline Solution in Heart Failure

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT00555685

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Renal Failure Hyponatremia	Drug: NaCl 7,5% (Hypertonic Saline Solution) Drug: NaCl 0,9%	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Hypertonic Saline Solution in Decompensated Heart Failure

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: A

Group of patients that will receive hypertonic saline solution (NaCl 7,5%)

Drug: NaCl 7,5% (Hypertonic Saline Solution)

Patients in the intervention arm will receive 100ml of NaCl 7,5, twice daily during 3 days

Placebo Comparator: B

Group of patients that will receive placebo

Drug: NaCl 0,9%

Patients in the placebo arm will receive 100ml of NaCl 0,9% twice daily during 3 days

Outcome Measures

Primary Outcome Measures

Occurrence of renal disfunction [During hospital admission]

Secondary Outcome Measures

Improvement of hyponatremia [During hospital admission]
Improvement of congestive phenomena [During hospital admission]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.