Heart FailurePhase 3SODIUM-HFNCT02012179
SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure
A Phase 3 study testing Low sodium diet in people with Heart Failure, run by University of Alberta at 26 sites in 5 countries.
Trial summary
SODIUM-HF is a multicenter clinical trial in ambulatory patients with chronic HF to evaluate the efficacy of a low sodium containing diet on a composite clinical outcome composed of of all-cause mortality, cardiovascular hospitalizations and cardiovascular emergency department visits. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 806 participants
- Where
- 26 sitesin 5 countries
- Study dates
- 24 Mar 2014to Jan 2023
- Phase
- Phase 3
- 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 recruited if they are 18+ years or older, with confirmed diagnosis of HF (both reduced and preserved systolic function are eligible), NYHA class II-III, and willing to sign informed consent.
Who cannot join
- Subjects will be excluded if:
- Average dietary intake of <1500 mg/ day by a quantitative or semi-quantitative method
- Serum sodium <130mmol/L
- Renal failure (glomerular filtration rate <30 mL/min)
- Hepatic failure
- Uncontrolled thyroid disorder
Show all 13Show fewer
- Cardiac device (ICD or CRT) or revascularization procedure (PCI or CABG) in previous month or planned in next 3 months
- Hospitalization due to cardiovascular causes in previous 1 month
- Uncontrolled atrial fibrillation (resting heart rate >90 bpm)
- Active malignancy
- Moderate-severe dementia
- Enrolled in another interventional research study
- 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
26 sites in 5 countries.
26 sites in 5 countries
Canada17 sites
Brampton Research Associates
Brampton, Ontario
University of Calgary / Foothills Medical Centre
Calgary, Alberta
St. Mary's Hospital
Camrose, Alberta
Private Cardiology Practice
Delta, British Columbia
University of Alberta Hospital
Edmonton, Alberta
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia
Hamilton Health Sciences
Hamilton, Ontario
Southlake Regional Health Centre
Newmarket, Ontario
Red Deer Regional Hospital
Red Deer, Alberta
Prairie Vascular Research Inc.
Regina, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan
Curans Heart Centre
Thunder Bay, Ontario
St. Michael's Hospital
Toronto, Ontario
Toronto General Hospital
Toronto, Ontario
St. Paul's Hospital
Vancouver, British Columbia
Vancouver General Hospital
Vancouver, British Columbia
St. Boniface Hospital
Winnipeg, Manitoba
Australia3 sites
The Prince Charles Hospital
Chermside
St. Vincent's Hospital Sydney
Darlinghurst
Metro North Hospital and Health Service
Herston
New Zealand3 sites
Middlemore Clinical Trials
Auckland
University of Auckland
Auckland
Christchurch Heart Institute / University of Otago
Christchurch
Chile2 sites
Hospital Base Osorno
Osorno
Centro de estudios cardiologicas y de Medicine Interna Ltda (Centre for Cardiology and Internal Medicine Studies)
Temuco
Mexico1 site
Unidad de Investigación en Epidemiología Clínica Hospital General Regional No. 1, IMSS
Mexico City
About this study
Official title: The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure
SODIUM-HF is a multicenter clinical trial in ambulatory patients with chronic HF to evaluate the efficacy of a low sodium containing diet on a composite clinical outcome composed of of all-cause mortality, cardiovascular hospitalizations and cardiovascular emergency department visits. The hypothesis of this study is that patients following a low-sodium containing diet will have fewer clinical events (fewer hospital readmissions or emergency department visits, longer survival) than those randomized to Usual Care.
- Conditions
- Heart Failure
- Being tested
- Low sodium diet
- Keywords
- Diet, Dietary sodium reduction, Salt restriction, Nutrition
- 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 dietOther
Low sodium diet (65 mmol or 1500 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Low sodium diet | Experimental | Low sodium diet (65 mmol or 1500 mg/day) Receives: Other: Low sodium diet |
| Usual Care | No intervention | General advice to limit dietary sodium as it is provided during routine clinic practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Clinical Outcomes
All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits
Measured: 12 months
Secondary outcomes (3)
Exercise capacity
Change in exercise capacity as measured by the 6-minute walk test (6MWT)
Measured: 12 months
NYHA functional class
Change in NYHA class treated as a categorical variable
Measured: 12 months
Quality of life (KCCQ)
Change in quality of life assessed by the KCCQ
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 posted16 Dec 2013 (estimated)
- Study start24 Mar 2014
- Primary completionSep 2022
- Study completionJan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 806 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin Ezekowitz, MBBCh, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012179
- Sponsor's protocol ID
- MOP130275
- Acronym
- SODIUM-HF
- Status last verified
- Jan 2023
- First submitted
- 10 Dec 2013
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ezekowitz JA, Colin-Ramirez E, Ross H, Escobedo J, Macdonald P, Troughton R, Saldarriaga C, Alemayehu W, McAlister FA, Arcand J, Atherton J, Doughty R, Gupta M, Howlett J, Jaffer S, Lavoie A, Lund M, Marwick T, McKelvie R, Moe G, Pandey AS, Porepa L, Rajda M, Rheault H, Singh J, Toma M, Virani S, Zieroth S; SODIUM-HF Investigators. Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial. Lancet. 2022 Apr 9;399(10333):1391-1400. doi: 10.1016/S0140-6736(22)00369-5. Epub 2022 Apr 2.
PubMed 35381194Colin-Ramirez E, Ezekowitz JA; SODIUM-HF investigators. Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF). Am Heart J. 2018 Nov;205:87-96. doi: 10.1016/j.ahj.2018.08.005. Epub 2018 Aug 16.
PubMed 30205241
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. 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
- NCT02012179
- Acronym / sponsor ID
- SODIUM-HF / MOP130275
- Conditions
- Heart Failure
- Keywords
- Diet, Dietary sodium reduction, Salt restriction, Nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 806 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 24 Mar 2014 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 16 Dec 2013 (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.
SODIUM-HF is a multicenter clinical trial in ambulatory patients with chronic HF to evaluate the efficacy of a low sodium containing diet on a composite clinical outcome composed of of all-cause mortality, cardiovascular hospitalizations and cardiovascular emergency department visits. The hypothesis of this study is that patients following a low-sodium containing diet will have fewer clinical events (fewer hospital readmissions or emergency department visits, longer survival) than those randomized to Usual Care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low sodium diet | Experimental | Other: Low sodium dietLow sodium diet (65 mmol or 1500 mg/day) |
| Usual Care | No intervention | –General advice to limit dietary sodium as it is provided during routine clinic practice |
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 recruited if they are 18+ years or older, with confirmed diagnosis of HF (both reduced and preserved systolic function are eligible), NYHA class II-III, and willing to sign informed consent.
Key exclusion criteria (13 listed)
- Average dietary intake of <1500 mg/ day by a quantitative or semi-quantitative method
- Serum sodium <130mmol/L
- Renal failure (glomerular filtration rate <30 mL/min)
- Hepatic failure
- Uncontrolled thyroid disorder
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 dietLow sodium diet (65 mmol or 1500 mg/day) | Other | Low sodium diet |
Primary outcome
Composite Clinical Outcomes
Time frame: 12 months
All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits
3 secondary outcomes
Exercise capacity
Time frame: 12 months
NYHA functional class
Time frame: 12 months
Quality of life (KCCQ)
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 31 Jan 2023.
- Derived from this study: PubMed 35381194Ezekowitz JA, Colin-Ramirez E, Ross H, Escobedo J, Macdonald P, Troughton R, Saldarriaga C, Alemayehu W, McAlister FA, Arcand J, Atherton J, Doughty R, Gupta M, Howlett J, Jaffer S, Lavoie A, Lund M, Marwick T, McKelvie R, Moe G, Pandey AS, Porepa L, Rajda M, Rheault H, Singh J, Toma M, Virani S, Zieroth S; SODIUM-HF Investigators. Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial. Lancet. 2022 Apr 9;399(10333):1391-1400. doi: 10.1016/S0140-6736(22)00369-5. Epub 2022 Apr 2.
- Derived from this study: PubMed 30205241Colin-Ramirez E, Ezekowitz JA; SODIUM-HF investigators. Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF). Am Heart J. 2018 Nov;205:87-96. doi: 10.1016/j.ahj.2018.08.005. Epub 2018 Aug 16.
- Individual participant dataSharing planned: No
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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 principal investigator
University of Alberta
26 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low sodium diet in people with Heart Failure, run by University of Alberta at 26 sites in 5 countries.
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 13 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 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Canada, Australia, New Zealand, Chile, Mexico. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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 NCT02012179, which also lists 2 linked publications.
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 31 Jan 2023.