Study of Dietary Intervention Under 100 MMOL in Heart Failure
SODIUM-HF
The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure
1 other identifier
interventional
38
1 country
1
Brief Summary
This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Mar 2012
Typical duration for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2011
CompletedFirst Posted
Study publicly available on registry
November 28, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedJune 9, 2022
December 1, 2014
2.7 years
November 23, 2011
June 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
composite clinical outcomes
(cardiovascular hospitalizations, emergency department visits due acute decompensated HF, and all-cause mortality) in patients with stable HF
12 months
Secondary Outcomes (2)
symptoms and quality of life
12 months
reduces natriuretic peptide levels
12 months
Study Arms (2)
low-sodium diet
EXPERIMENTAL(1500 mg daily)
moderate-sodium diet
NO INTERVENTIONsodium (100 mmol or 2300 mg daily; Usual Care)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alberta
Edmonton, Alberta, T6G 2B7, Canada
Related Publications (1)
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.
PMID: 28531423DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Justin Ezekowitz, MBBCh MSc
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2011
First Posted
November 28, 2011
Study Start
March 1, 2012
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
June 9, 2022
Record last verified: 2014-12