Clinical InvestigationShort-Term Effects of Hypertonic Saline Solution in Acute Heart Failure and Long-Term Effects of a Moderate Sodium Restriction in Patients With Compensated Heart Failure With New York Heart Association Class III (Class C) (SMAC-HF Study)
Section snippets
MATERIALS AND METHODS
The target population for this trial was patients with NYHA class III HF from ischemic or nonischemic origin. The patients signed informed consent and release of medical information forms before enrolment. The ethical committee approved the protocol only as single-blind study.
RESULTS
Of the 4728 patients consecutively admitted to hospital with worsening HF, 1578 were in NYHA class > III, 158 in NYHA class < III, 143 showed cerebral vascular disease or dementia, 61 cancer, 96 uncompensated diabetes, 85 inability to give informed consent and 63 severe hepatic disease, 186 required pacemaker implantation, 43 had previous cardiac resynchronization therapy implantation and 83 an alcoholic habit. Only 37 patients maintained the NYHA class III at discharge, 139 declined to take
DISCUSSION
The study explores the sodium management in patients with HF both in acute phases (hospitalization) and in chronic phases (after discharge) when the patients had reached a compensated state. Although, in the acute phase, the HSS determined a faster resolution of congestive state without determining renal dysfunction or Na reduction and renin angiotensin aldosterone system (RAAS) activation, in the chronic phases (compensated state), a moderate Na restriction allowed to maintain a good renal
ACKNOWLEDGMENTS
We sincerely thank Prof. Michael H. Alderman for his invaluable contribution and assistance in this manuscript preparation.
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ClinTrials Gov. NCT01156337.