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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01156337
First Posted: July 2, 2010
Last Update Posted: November 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Palermo
University of Naples
Buccheri La Ferla Hospital
Information provided by:
Ospedale G. F. Ingrassia
  Purpose
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.

Condition
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)
Groups/Cohorts
low sodium diet 80 mmol/day
moderate sodium intake 120 mmol/day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in III NYHA class HF
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156337


Locations
Italy
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

ClinicalTrials.gov Identifier: NCT01156337     History of Changes
Other Study ID Numbers: G.F. Ingrassia Hospital,Italy
First Submitted: July 1, 2010
First Posted: July 2, 2010
Last Update Posted: November 21, 2011
Last Verified: August 2007

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases