SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure

NCT ID: NCT02012179

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 806 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-24
• Study Completion Date: 2023-01-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low sodium diet

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

Group Type: EXPERIMENTAL

Low sodium diet

Intervention Type: OTHER

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

Usual Care

General advice to limit dietary sodium as it is provided during routine clinic practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Low sodium diet

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Justin Ezekowitz, MBBCh

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

The Prince Charles Hospital

Chermside, , Australia

St. Vincent's Hospital Sydney

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

Countries

Australia; Canada; Chile; Mexico; New Zealand

References

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.

Reference Type: DERIVED

PMID: 35381194 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30205241 (View on PubMed)

Other Identifiers

MOP130275

Identifier Type: -

Identifier Source: org_study_id