SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02012179 |
Recruitment Status :
Active, not recruiting
First Posted : December 16, 2013
Last Update Posted : July 11, 2022
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Sponsor:
University of Alberta
Information provided by (Responsible Party):
University of Alberta
Tracking Information | ||||
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First Submitted Date ICMJE | December 10, 2013 | |||
First Posted Date ICMJE | December 16, 2013 | |||
Last Update Posted Date | July 11, 2022 | |||
Actual Study Start Date ICMJE | March 24, 2014 | |||
Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Composite Clinical Outcomes [ Time Frame: 12 months ] All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure | |||
Official Title ICMJE | The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Heart Failure | |||
Intervention ICMJE | Other: Low sodium diet
Low sodium diet (65 mmol or 1500 mg/day)
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
806 | |||
Original Estimated Enrollment ICMJE |
1000 | |||
Estimated Study Completion Date ICMJE | December 2023 | |||
Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Subjects will be excluded if:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Canada, Chile, Mexico, New Zealand | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02012179 | |||
Other Study ID Numbers ICMJE | MOP130275 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | University of Alberta | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | University of Alberta | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University of Alberta | |||
Verification Date | July 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |