Sodium Management in Acute and Chronic Heart Failure

Heart Failure Clinical Trial

— SMAC-HF  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156337
• Other study ID #: G.F. Ingrassia Hospital,Italy
• Status: Completed
• Phase: N/A
• First received: July 1, 2010
• Last updated: November 18, 2011
• Start date: September 2000
• Est. completion date: March 2010

Study information

• Verified date: August 2007
• Source: Ospedale G. F. Ingrassia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Italy	GF Ingrassia Hospital	Palermo

Sponsors (4)

Lead Sponsor	Collaborator
Ospedale G. F. Ingrassia	Buccheri La Ferla Hospital, University of Naples, University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	readmission for HF worsening
Secondary	mortality