Back to resultsStudy of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
low-sodium diet (1500 mg daily)
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Patients with stable heart failure
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Alberta
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
low-sodium diet
moderate-sodium diet
Arm Description
(1500 mg daily)
sodium (100 mmol or 2300 mg daily; Usual Care)
Outcomes
Primary Outcome Measures
composite clinical outcomes
(cardiovascular hospitalizations, emergency department visits due acute decompensated HF, and all-cause mortality) in patients with stable HF
Secondary Outcome Measures
symptoms and quality of life
improves symptoms and quality of life for patients with stable HF
reduces natriuretic peptide levels
reduces natriuretic peptide levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01480401
Brief Title
Study of Dietary Intervention Under 100 MMOL in Heart Failure
Acronym
SODIUM-HF
Official Title
The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Patients with stable heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low-sodium diet
Arm Type
Experimental
Arm Description
(1500 mg daily)
Arm Title
moderate-sodium diet
Arm Type
No Intervention
Arm Description
sodium (100 mmol or 2300 mg daily; Usual Care)
Intervention Type
Other
Intervention Name(s)
low-sodium diet (1500 mg daily)
Primary Outcome Measure Information:
Title
composite clinical outcomes
Description
(cardiovascular hospitalizations, emergency department visits due acute decompensated HF, and all-cause mortality) in patients with stable HF
Time Frame
12 months
Secondary Outcome Measure Information:
Title
symptoms and quality of life
Description
improves symptoms and quality of life for patients with stable HF
Time Frame
12 months
Title
reduces natriuretic peptide levels
Description
reduces natriuretic peptide levels
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Ezekowitz, MBBCh MSc
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28531423
Citation
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.
Results Reference
derived
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Study of Dietary Intervention Under 100 MMOL in Heart Failure
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