- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01156337
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
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Palermo, Italy, 90100
- GF Ingrassia Hospital
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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 |
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low sodium diet 80 mmol/day
|
moderate sodium intake 120 mmol/day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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readmission for HF worsening
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Secondary Outcome Measures
Outcome Measure |
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mortality
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- G.F. Ingrassia Hospital,Italy
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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