Sodium Management in Acute and Chronic Heart Failure

Completed

• Conditions: Heart Failure

• Registration Number: NCT01156337
• Lead Sponsor: Ospedale G. F. Ingrassia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-09
• Status Verified: 2007-08
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Last Update Submitted: 2011-11-18
• Last Update Posted: 2011-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
readmission for HF worsening

Secondary Outcome Measures

Name	Time	Method
mortality

Trial Locations

Locations (1)

GF Ingrassia Hospital; 🇮🇹 Palermo, Italy