SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF)
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| ClinicalTrials.gov Identifier: NCT02012179 |
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Recruitment Status :
Completed
First Posted : December 16, 2013
Last Update Posted : January 31, 2023
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Sponsor:
University of Alberta
Information provided by (Responsible Party):
University of Alberta
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Brief 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. 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure | Other: Low sodium diet | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 806 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure |
| Actual Study Start Date : | March 24, 2014 |
| Actual Primary Completion Date : | September 2022 |
| Actual Study Completion Date : | January 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Low sodium diet
Low sodium diet (65 mmol or 1500 mg/day)
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Other: Low sodium diet
Low sodium diet (65 mmol or 1500 mg/day) |
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No Intervention: Usual Care
General advice to limit dietary sodium as it is provided during routine clinic practice
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Primary Outcome Measures :
- Composite Clinical Outcomes [ Time Frame: 12 months ]All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits
Secondary Outcome Measures :
- Exercise capacity [ Time Frame: 12 months ]Change in exercise capacity as measured by the 6-minute walk test (6MWT)
- NYHA functional class [ Time Frame: 12 months ]Change in NYHA class treated as a categorical variable
- Quality of life (KCCQ) [ Time Frame: 12 months ]Change in quality of life assessed by the KCCQ
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02012179
Locations
Show 26 study locations
Sponsors and Collaborators
University of Alberta
Investigators
| Principal Investigator: | Justin Ezekowitz, MBBCh | University of Alberta |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Alberta |
| ClinicalTrials.gov Identifier: | NCT02012179 |
| Other Study ID Numbers: |
MOP130275 |
| First Posted: | December 16, 2013 Key Record Dates |
| Last Update Posted: | January 31, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by University of Alberta:
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Diet Dietary sodium reduction Salt restriction Nutrition |
Additional relevant MeSH terms:
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Heart Failure Heart Diseases Cardiovascular Diseases |