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Sodium Management in Acute and Chronic Heart Failure (SMAC-HF)

O

Ospedale G. F. Ingrassia

Status

Completed

Conditions

Heart Failure

Study type

Observational

Funder types

Other

Identifiers

NCT01156337
G.F. Ingrassia Hospital,Italy

Details and patient eligibility

About

The study was aimed to verify the effects of Hypertonic saline solution (HSS) and a moderate sodium (Na) restriction plus high furosemide dose in the short term (hospitalization time) and a moderate Na restriction in the long term on readmissions and mortality in patients in III NYHA class.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Decompensated HF due to ischemic or nonischemic cardiomyopathy,
  • >18 years of age,
  • HF according to Framingham criteria
  • NYHA functional class III
  • EF <40%,
  • Serum creatinine <2,5 mg/dL
  • BUN <60 mg/dL,

Exclusion criteria

  • NYHA class > III or < III,
  • Cerebral vascular disease,
  • Dementia,
  • Cancer,
  • Uncompensated diabetes,
  • Severe hepatic disease
  • Patients requiring pacemaker
  • Previous RCT implantation
  • Alcoholic habit

Trial design

0 participants in 2 patient groups

low sodium diet 80 mmol/day
moderate sodium intake 120 mmol/day

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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