Heart FailureSMAC-HFNCT01156337
Sodium Management in Acute and Chronic Heart Failure
An observational study of Heart Failure, run by Ospedale G. F. Ingrassia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Sep 2000to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in III NYHA class HF
Who may be able to join
- 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,
Who cannot join
- NYHA class > III or < III,
- Cerebral vascular disease,
- Dementia,
- Cancer,
- Uncompensated diabetes,
- Severe hepatic disease
Show all 9Show fewer
- Patients requiring pacemaker
- Previous RCT implantation
- Alcoholic habit
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Heart Failure
- Keywords
- Heart failure III NYHA class, Furosemide, Sodium, water restriction, decompensated heart failure, Hypertonic saline solution, Moderate sodium restriction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| low sodium diet 80 mmol/day | Not described | |
| moderate sodium intake 120 mmol/day | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
readmission for HF worsening
Secondary outcomes (1)
mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startSep 2000
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Ospedale G. F. Ingrassia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Palermo, University of Naples, Buccheri La Ferla Hospital, Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156337
- Sponsor's protocol ID
- G.F. Ingrassia Hospital,Italy
- Acronym
- SMAC-HF
- Status last verified
- Aug 2007
- First submitted
- 1 Jul 2010
- Last updated
- 21 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01156337
- Acronym / sponsor ID
- SMAC-HF / G.F. Ingrassia Hospital,Italy
- Conditions
- Heart Failure
- Keywords
- Heart failure III NYHA class, Furosemide, Sodium, water restriction, decompensated heart failure, Hypertonic saline solution, Moderate sodium restriction
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Ospedale G. F. IngrassiaUniversity, hospital or other
- Collaborators
- University of Palermo, University of Naples, Buccheri La Ferla Hospital, Palermo
- Study start
- Sep 2000
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 2 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low sodium diet 80 mmol/day | – | – |
| moderate sodium intake 120 mmol/day | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in III NYHA class HF
Key inclusion criteria (7 listed)
- Decompensated HF due to ischemic or nonischemic cardiomyopathy,
- >18 years of age,
- HF according to Framingham criteria
- NYHA functional class III
- EF <40%,
Key exclusion criteria (9 listed)
- NYHA class > III or < III,
- Cerebral vascular disease,
- Dementia,
- Cancer,
- Uncompensated diabetes,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
readmission for HF worsening
1 secondary outcome
mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Ospedale G. F. Ingrassia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
readmission for HF worsening. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2011.