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

November 18, 2011 updated by: Ospedale G. F. Ingrassia

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.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Palermo, Italy, 90100
        • GF Ingrassia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in III NYHA class HF

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
readmission for HF worsening

Secondary Outcome Measures

Outcome Measure
mortality

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

July 1, 2010

First Submitted That Met QC Criteria

July 1, 2010

First Posted (Estimate)

July 2, 2010

Study Record Updates

Last Update Posted (Estimate)

November 21, 2011

Last Update Submitted That Met QC Criteria

November 18, 2011

Last Verified

August 1, 2007

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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