Heart FailurePhase 4NCT01738659
Estimated Echocardiographic Pulmonary Capillary Wedge Pressure in Heart Failure
A Phase 4 study testing normal sodium diet in people with Heart Failure, run by University of Palermo.
Trial summary
The aim of the study was to verify the effects of moderate versus low sodium intake on pulmonary capillary wedge pressure (PCWP), determined by Doppler echocardiography and tissue Doppler imaging in patients suffering from compensated heart failure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- normal sodium diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Sep 2012
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- compensated HF patients
Who cannot join
- decompensated HF patients
About this study
Official title: Moderate Versus Low Sodium Diet Intake Effects on Estimated Echocardiographic Pulmonary Capillary Wedge Pressure During 12 Months of Follow up in Compensated Heart Failure Patients.
The aim of the study was to verify the effects of moderate versus low sodium intake on pulmonary capillary wedge pressure (PCWP), determined by Doppler echocardiography and tissue Doppler imaging in patients suffering from compensated heart failure.
Read the detailed description
the study outcome is hospital readmission and mortality after 12 months of two different sodium diet.
- Conditions
- Heart Failure
- Being tested
- normal sodium diet
- Keywords
- sodium ,diuretics, PCWP
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal sodium dietDietary supplement
normal sodium diet (120 mmol/daily) for 1 year
| Study group | Role | What they receive |
|---|---|---|
| normal sodium diet (120 mmol/die) | Experimental | active comparator: low sodium diet (80 mmol/die) Receives: Dietary Supplement: normal sodium diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of hospital readmitted patients
every six months we measure the PCWP by echocardiography
Measured: 1 year
Secondary outcomes (1)
number of death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startOct 2008
- Primary completionDec 2010
- Study completionSep 2012
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale G. F. Ingrassia
- Responsible party
- Principal investigator, Gaspare Parrinello, University of Palermo
- Investigators
- pietro di pasquale, MD, Principal investigator, G.F. Ingrassia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738659
- Sponsor's protocol ID
- UNIPA
- Status last verified
- Nov 2012
- First submitted
- 23 Oct 2012
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate Versus Low Sodium Diet Intake Effects on Estimated Echocardiographic Pulmonary Capillary Wedge Pressure During 12 Months of Follow up in Compensated Heart Failure Patients.
- ClinicalTrials.gov ID
- NCT01738659
- Acronym / sponsor ID
- UNIPA
- Conditions
- Heart Failure
- Keywords
- sodium ,diuretics, PCWP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Collaborators
- Ospedale G. F. Ingrassia
- Study start
- Oct 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Nov 2012 (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 aim of the study was to verify the effects of moderate versus low sodium intake on pulmonary capillary wedge pressure (PCWP), determined by Doppler echocardiography and tissue Doppler imaging in patients suffering from compensated heart failure.
Detailed description
the study outcome is hospital readmission and mortality after 12 months of two different sodium diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| normal sodium diet (120 mmol/die) | Experimental | Dietary Supplement: normal sodium dietactive comparator: low sodium diet (80 mmol/die) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- compensated HF patients
Key exclusion criteria (1 listed)
- decompensated HF patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal sodium dietnormal sodium diet (120 mmol/daily) for 1 year | Dietary supplement | normal sodium diet (120 mmol/die) |
Primary outcome
number of hospital readmitted patients
Time frame: 1 year
every six months we measure the PCWP by echocardiography
1 secondary outcome
number of death
Time frame: 1 year
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 30 Nov 2012.
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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.
pietro di pasquale, MD principal investigator
G.F. Ingrassia Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing normal sodium diet in people with Heart Failure, run by University of Palermo.
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 1 inclusion and 1 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 30 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
number of hospital readmitted patients (time frame: 1 year). 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 30 Nov 2012.