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

Heart Failure Clinical Trial

— SODIUM-HF  

Official title:

The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012179
• Other study ID #: MOP130275
• Status: Completed
• Phase: Phase 3
• Start date: March 24, 2014
• Est. completion date: January 2023

Study information

• Verified date: January 2023
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 806
• Est. completion date: January 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital	Chermside
Australia	St. Vincent's Hospital Sydney	Darlinghurst
Australia	Metro North Hospital and Health Service	Herston
Canada	Brampton Research Associates	Brampton	Ontario
Canada	University of Calgary / Foothills Medical Centre	Calgary	Alberta
Canada	St. Mary's Hospital	Camrose	Alberta
Canada	Private Cardiology Practice	Delta	British Columbia
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Red Deer Regional Hospital	Red Deer	Alberta
Canada	Prairie Vascular Research Inc.	Regina	Saskatchewan
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Curans Heart Centre	Thunder Bay	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	St. Boniface Hospital	Winnipeg	Manitoba
Chile	Hospital Base Osorno	Osorno
Chile	Centro de estudios cardiologicas y de Medicine Interna Ltda (Centre for Cardiology and Internal Medicine Studies)	Temuco
Mexico	Unidad de Investigación en Epidemiología Clínica Hospital General Regional No. 1, IMSS	Mexico City
New Zealand	Middlemore Clinical Trials	Auckland
New Zealand	University of Auckland	Auckland
New Zealand	Christchurch Heart Institute / University of Otago	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Countries where clinical trial is conducted

Australia,  Canada,  Chile,  Mexico,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Clinical Outcomes	All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits	12 months
Secondary	Exercise capacity	Change in exercise capacity as measured by the 6-minute walk test (6MWT)	12 months
Secondary	NYHA functional class	Change in NYHA class treated as a categorical variable	12 months
Secondary	Quality of life (KCCQ)	Change in quality of life assessed by the KCCQ	12 months

External Links

•   SODIUM-HF Webpage