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

Phase 3

Completed

• Conditions: Heart Failure

• 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

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

Trial Locations

Locations (26)

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

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