Clinical trial NCT02012179: SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure
Official title: The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Keywords: Diet
Dietary sodium reduction
Salt restriction
Nutrition
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 806
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Composite Clinical Outcomes
timeFrame: 12 months
Secondary outcomes:
measure: Exercise capacity
timeFrame: 12 months
measure: NYHA functional class
timeFrame: 12 months
measure: Quality of life (KCCQ)
timeFrame: 12 months
Other outcomes:
Locations:
city: Chermside
country: Australia
facility: The Prince Charles Hospital
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital Sydney
city: Herston
country: Australia
facility: Metro North Hospital and Health Service
city: Calgary
country: Canada
facility: University of Calgary / Foothills Medical Centre
state: Alberta
city: Camrose
country: Canada
facility: St. Mary's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Red Deer
country: Canada
facility: Red Deer Regional Hospital
state: Alberta
city: Delta
country: Canada
facility: Private Cardiology Practice
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Brampton
country: Canada
facility: Brampton Research Associates
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: Curans Heart Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Regina
country: Canada
facility: Prairie Vascular Research Inc.
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Osorno
country: Chile
facility: Hospital Base Osorno
city: Temuco
country: Chile
facility: Centro de estudios cardiologicas y de Medicine Interna Ltda (Centre for Cardiology and Internal Medicine Studies)
city: Mexico City
country: Mexico
facility: Unidad de Investigación en Epidemiología Clínica Hospital General Regional No. 1, IMSS
city: Auckland
country: New Zealand
facility: Middlemore Clinical Trials
city: Auckland
country: New Zealand
facility: University of Auckland
city: Christchurch
country: New Zealand
facility: Christchurch Heart Institute / University of Otago
Study officials:
affiliation: University of Alberta
name: Justin Ezekowitz, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ezekowitz JA, Colin-Ramirez E, Ross H, Escobedo J, Macdonald P, Troughton R, Saldarriaga C, Alemayehu W, McAlister FA, Arcand J, Atherton J, Doughty R, Gupta M, Howlett J, Jaffer S, Lavoie A, Lund M, Marwick T, McKelvie R, Moe G, Pandey AS, Porepa L, Rajda M, Rheault H, Singh J, Toma M, Virani S, Zieroth S; SODIUM-HF Investigators. Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial. Lancet. 2022 Apr 9;399(10333):1391-1400. doi: 10.1016/S0140-6736(22)00369-5. Epub 2022 Apr 2.
citation: Colin-Ramirez E, Ezekowitz JA; SODIUM-HF investigators. Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF). Am Heart J. 2018 Nov;205:87-96. doi: 10.1016/j.ahj.2018.08.005. Epub 2018 Aug 16.