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

This study has been completed.
University of Palermo
University of Naples
Buccheri La Ferla Hospital
Information provided by:
Ospedale G. F. Ingrassia Identifier:
First received: July 1, 2010
Last updated: November 18, 2011
Last verified: August 2007

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.

Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sodium Management in Acute and Chronic Phases in Patients With New York Heart Association Class III (Class C) Heart Failure. Short and Long Term Findings.

Resource links provided by NLM:

Further study details as provided by Ospedale G. F. Ingrassia:

Primary Outcome Measures:
  • readmission for HF worsening

Secondary Outcome Measures:
  • mortality

Study Start Date: September 2000
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
low sodium diet 80 mmol/day
moderate sodium intake 120 mmol/day


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients in III NYHA class HF


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
  Contacts and Locations
Please refer to this study by its identifier: NCT01156337

GF Ingrassia Hospital
Palermo, Italy, 90100
Sponsors and Collaborators
Ospedale G. F. Ingrassia
University of Palermo
University of Naples
Buccheri La Ferla Hospital
  More Information

No publications provided Identifier: NCT01156337     History of Changes
Other Study ID Numbers: G.F. Ingrassia Hospital,Italy
Study First Received: July 1, 2010
Last Updated: November 18, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Ospedale G. F. Ingrassia:
Heart failure III NYHA class
water restriction
decompensated heart failure
Hypertonic saline solution
Moderate sodium restriction

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on April 17, 2014