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

Phase 3

Completed

• Conditions: Heart Failure
• Interventions: Other: Low sodium diet

• Registration Number: NCT02012179
• Lead Sponsor: University of Alberta

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-16
• Study Start: 2014-03-24
• Primary Completion: 2022-09
• Status Verified: 2023-01
• Study Completion: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 806

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Composite Clinical Outcomes	12 months	All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits

Secondary Outcome Measures

Name	Time	Method
Quality of life (KCCQ)	12 months	Change in quality of life assessed by the KCCQ
Exercise capacity	12 months	Change in exercise capacity as measured by the 6-minute walk test (6MWT)
NYHA functional class	12 months	Change in NYHA class treated as a categorical variable

Trial Locations

Locations (26)

St. Vincent's Hospital Sydney; 🇦🇺 Darlinghurst, Australia

Brampton Research Associates; 🇨🇦 Brampton, Ontario, Canada

Red Deer Regional Hospital; 🇨🇦 Red Deer, Alberta, Canada

Metro North Hospital and Health Service; 🇦🇺 Herston, Australia

University of Calgary / Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

University of Auckland; 🇳🇿 Auckland, New Zealand

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

St. Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Curans Heart Centre; 🇨🇦 Thunder Bay, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Christchurch Heart Institute / University of Otago; 🇳🇿 Christchurch, New Zealand

The Prince Charles Hospital; 🇦🇺 Chermside, Australia

St. Mary's Hospital; 🇨🇦 Camrose, Alberta, Canada

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada

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

Private Cardiology Practice; 🇨🇦 Delta, British Columbia, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Prairie Vascular Research Inc.; 🇨🇦 Regina, Saskatchewan, Canada

Hospital Base Osorno; 🇨🇱 Osorno, Chile

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

Middlemore Clinical Trials; 🇳🇿 Auckland, New Zealand

Southlake Regional Health Centre; 🇨🇦 Newmarket, Ontario, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Queen Elizabeth II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada