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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02012179




Registration number
NCT02012179
Ethics application status
Date submitted
10/12/2013
Date registered
16/12/2013
Date last updated
8/04/2019

Titles & IDs
Public title
SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure
Scientific title
The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure
Secondary ID [1] 0 0
MOP130275
Universal Trial Number (UTN)
Trial acronym
SODIUM-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Low sodium diet

Experimental: Low sodium diet - Low sodium diet (65 mmol or 1500 mg/day)

No Intervention: Usual Care - General advice to limit dietary sodium as it is provided during routine clinic practice


Other interventions: Low sodium diet
Low sodium diet (65 mmol or 1500 mg/day)

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite Clinical Outcomes - All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Exercise capacity - Change in exercise capacity as measured by the 6-minute walk test (6MWT)
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
NYHA functional class - Change in NYHA class treated as a categorical variable
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Quality of life (KCCQ) - Change in quality of life assessed by the KCCQ
Timepoint [3] 0 0
12 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Metro North Hospital and Health Service - Herston
Recruitment postcode(s) [1] 0 0
- Chermside
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Herston
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
Nova Scotia
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Saskatchewan
Country [7] 0 0
Chile
State/province [7] 0 0
Osorno
Country [8] 0 0
Chile
State/province [8] 0 0
Temuco
Country [9] 0 0
Mexico
State/province [9] 0 0
Mexico City
Country [10] 0 0
New Zealand
State/province [10] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
University of Alberta
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02012179
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Justin Ezekowitz, MBBCh
Address 0 0
University of Alberta
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Eloisa Colin, PhD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
sodiumhf@ualberta.ca
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02012179