Heart FailureSODIUM-HFNCT01480401
Study of Dietary Intervention Under 100 MMOL in Heart Failure
A study testing low-sodium diet (1500 mg daily) in people with Heart Failure, run by University of Alberta at 1 site in Canada.
Trial summary
This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- low-sodium diet (1500 mg daily)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Nov 2014
- Phase
- Interventional
- 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
Who may be able to join
- Patients will be recruited from each research center if they are 18 years or older, with confirmed diagnosis of Heart Failure (including both those with a reduced and preserved systolic function), NYHA II-IV, and willing to sign informed consent.
Who cannot join
- Subjects will be excluded if they have severe hyponatremia (serum sodium <130 mmol/L)
- Renal failure (a glomerular filtration rate < 30 mL/min)
- Uncontrolled thyroid disorders
- Hepatic failure
- Implantable cardiac device (ICD or CRT) or myocardial revascularization procedures (coronary angioplasty and/or surgical revascularization) in the previous 3 months
- Uncontrolled atrial fibrillation or recurrent ventricular arrhythmias
- Malignancy, or with moderate-severe dementia.
- Patients will be excluded if, in the opinion of the investigator, another condition exists that would preclude dietary compliance or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure
This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients.
- Conditions
- Heart Failure
- Being tested
- low-sodium diet (1500 mg daily)
- Keywords
- Patients with stable heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-sodium diet (1500 mg daily)Other
| Study group | Role | What they receive |
|---|---|---|
| low-sodium diet | Experimental | (1500 mg daily) Receives: Other: low-sodium diet (1500 mg daily) |
| moderate-sodium diet | No intervention | sodium (100 mmol or 2300 mg daily; Usual Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite clinical outcomes
(cardiovascular hospitalizations, emergency department visits due acute decompensated HF, and all-cause mortality) in patients with stable HF
Measured: 12 months
Secondary outcomes (2)
symptoms and quality of life
improves symptoms and quality of life for patients with stable HF
Measured: 12 months
reduces natriuretic peptide levels
reduces natriuretic peptide levels
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study startMar 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin Ezekowitz, MBBCh MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480401
- Sponsor's protocol ID
- 82-SH-01
- Acronym
- SODIUM-HF
- Status last verified
- Dec 2014
- First submitted
- 23 Nov 2011
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Colin-Ramirez E, McAlister FA, Zheng Y, Sharma S, Ezekowitz JA. Changes in dietary intake and nutritional status associated with a significant reduction in sodium intake in patients with heart failure. A sub-analysis of the SODIUM-HF pilot study. Clin Nutr ESPEN. 2016 Feb;11:e26-e32. doi: 10.1016/j.clnesp.2015.11.002. Epub 2015 Dec 29.
PubMed 28531423
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01480401
- Acronym / sponsor ID
- SODIUM-HF / 82-SH-01
- Conditions
- Heart Failure
- Keywords
- Patients with stable heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Nov 2011 (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.
This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-sodium diet | Experimental | Other: low-sodium diet (1500 mg daily)(1500 mg daily) |
| moderate-sodium diet | No intervention | –sodium (100 mmol or 2300 mg daily; Usual Care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will be recruited from each research center if they are 18 years or older, with confirmed diagnosis of Heart Failure (including both those with a reduced and preserved systolic function), NYHA II-IV, and willing to sign informed consent.
Key exclusion criteria (8 listed)
- Subjects will be excluded if they have severe hyponatremia (serum sodium <130 mmol/L)
- Renal failure (a glomerular filtration rate < 30 mL/min)
- Uncontrolled thyroid disorders
- Hepatic failure
- Implantable cardiac device (ICD or CRT) or myocardial revascularization procedures (coronary angioplasty and/or surgical revascularization) in the previous 3 months
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 |
|---|---|---|
| low-sodium diet (1500 mg daily) | Other | low-sodium diet |
Primary outcome
composite clinical outcomes
Time frame: 12 months
(cardiovascular hospitalizations, emergency department visits due acute decompensated HF, and all-cause mortality) in patients with stable HF
2 secondary outcomes
symptoms and quality of life
Time frame: 12 months
reduces natriuretic peptide levels
Time frame: 12 months
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 9 Jun 2022.
- Derived from this study: PubMed 28531423Colin-Ramirez E, McAlister FA, Zheng Y, Sharma S, Ezekowitz JA. Changes in dietary intake and nutritional status associated with a significant reduction in sodium intake in patients with heart failure. A sub-analysis of the SODIUM-HF pilot study. Clin Nutr ESPEN. 2016 Feb;11:e26-e32. doi: 10.1016/j.clnesp.2015.11.002. Epub 2015 Dec 29.
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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.
Justin Ezekowitz, MBBCh MSc principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-sodium diet (1500 mg daily) in people with Heart Failure, run by University of Alberta at 1 site in Canada.
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 8 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 9 Jun 2022. 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 Canada. 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?
composite clinical outcomes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01480401, which also lists 1 linked publication.
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 9 Jun 2022.