Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low sodium diet | Experimental | Low sodium diet (65 mmol or 1500 mg/day) |
|
| Usual Care | No Intervention | General advice to limit dietary sodium as it is provided during routine clinic practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low sodium diet | Other | Low sodium diet (65 mmol or 1500 mg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Clinical Outcomes | All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity | Change in exercise capacity as measured by the 6-minute walk test (6MWT) | 12 months |
| NYHA functional class | Change in NYHA class treated as a categorical variable |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded if:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Justin Ezekowitz, MBBCh | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Prince Charles Hospital | Chermside | Australia | ||||
| St. Vincent's Hospital Sydney |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35381194 | Derived | 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. | |
| 30205241 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 months |
| Quality of life (KCCQ) | Change in quality of life assessed by the KCCQ | 12 months |
| Darlinghurst |
| Australia |
| Metro North Hospital and Health Service | Herston | Australia |
| University of Calgary / Foothills Medical Centre | Calgary | Alberta | Canada |
| St. Mary's Hospital | Camrose | Alberta | Canada |
| University of Alberta Hospital | Edmonton | Alberta | Canada |
| Red Deer Regional Hospital | Red Deer | Alberta | Canada |
| Private Cardiology Practice | Delta | British Columbia | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | Canada |
| St. Boniface Hospital | Winnipeg | Manitoba | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | Canada |
| Brampton Research Associates | Brampton | Ontario | Canada |
| Hamilton Health Sciences | Hamilton | Ontario | Canada |
| Southlake Regional Health Centre | Newmarket | Ontario | Canada |
| Curans Heart Centre | Thunder Bay | Ontario | Canada |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| Toronto General Hospital | Toronto | Ontario | Canada |
| Prairie Vascular Research Inc. | Regina | Saskatchewan | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | Canada |
| Hospital Base Osorno | Osorno | Chile |
| Centro de estudios cardiologicas y de Medicine Interna Ltda (Centre for Cardiology and Internal Medicine Studies) | Temuco | Chile |
| Unidad de Investigación en Epidemiología Clínica Hospital General Regional No. 1, IMSS | Mexico City | Mexico |
| Middlemore Clinical Trials | Auckland | New Zealand |
| University of Auckland | Auckland | New Zealand |
| Christchurch Heart Institute / University of Otago | Christchurch | New Zealand |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004039 | Diet, Sodium-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided