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

This study has been completed.
Sponsor:
Collaborators:
University of Palermo
University of Naples
Buccheri La Ferla Hospital
Information provided by:
Ospedale G. F. Ingrassia
ClinicalTrials.gov Identifier:
NCT01156337
First received: July 1, 2010
Last updated: November 18, 2011
Last verified: August 2007
  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

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

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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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
Furosemide
Sodium
water restriction
decompensated heart failure
Hypertonic saline solution
Moderate sodium restriction

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 29, 2014