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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Low sodium diet
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Diet, Dietary sodium reduction, Salt restriction, Nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Prince Charles Hospital
  • St. Vincent's Hospital Sydney
  • Metro North Hospital and Health Service
  • University of Calgary / Foothills Medical Centre
  • St. Mary's Hospital
  • University of Alberta Hospital
  • Red Deer Regional Hospital
  • Private Cardiology Practice
  • St. Paul's Hospital
  • Vancouver General Hospital
  • St. Boniface Hospital
  • Queen Elizabeth II Health Sciences Centre
  • Brampton Research Associates
  • Hamilton Health Sciences
  • Southlake Regional Health Centre
  • Curans Heart Centre
  • St. Michael's Hospital
  • Toronto General Hospital
  • Prairie Vascular Research Inc.
  • Royal University Hospital
  • Hospital Base Osorno
  • Centro de estudios cardiologicas y de Medicine Interna Ltda (Centre for Cardiology and Internal Medicine Studies)
  • Unidad de Investigación en Epidemiología Clínica Hospital General Regional No. 1, IMSS
  • Middlemore Clinical Trials
  • University of Auckland
  • Christchurch Heart Institute / University of Otago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Low sodium diet

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Composite Clinical Outcomes
All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2013
Last Updated
January 30, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT02012179
Brief Title
SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure
Acronym
SODIUM-HF
Official Title
The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 24, 2014 (Actual)
Primary Completion Date
September 2022 (Actual)
Study Completion Date
January 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Diet, Dietary sodium reduction, Salt restriction, Nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
806 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low sodium diet
Arm Type
Experimental
Arm Description
Low sodium diet (65 mmol or 1500 mg/day)
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
General advice to limit dietary sodium as it is provided during routine clinic practice
Intervention Type
Other
Intervention Name(s)
Low sodium diet
Intervention Description
Low sodium diet (65 mmol or 1500 mg/day)
Primary Outcome Measure Information:
Title
Composite Clinical Outcomes
Description
All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Exercise capacity
Description
Change in exercise capacity as measured by the 6-minute walk test (6MWT)
Time Frame
12 months
Title
NYHA functional class
Description
Change in NYHA class treated as a categorical variable
Time Frame
12 months
Title
Quality of life (KCCQ)
Description
Change in quality of life assessed by the KCCQ
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Ezekowitz, MBBCh
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Prince Charles Hospital
City
Chermside
Country
Australia
Facility Name
St. Vincent's Hospital Sydney
City
Darlinghurst
Country
Australia
Facility Name
Metro North Hospital and Health Service
City
Herston
Country
Australia
Facility Name
University of Calgary / Foothills Medical Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
St. Mary's Hospital
City
Camrose
State/Province
Alberta
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Red Deer Regional Hospital
City
Red Deer
State/Province
Alberta
Country
Canada
Facility Name
Private Cardiology Practice
City
Delta
State/Province
British Columbia
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Brampton Research Associates
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Curans Heart Centre
City
Thunder Bay
State/Province
Ontario
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Prairie Vascular Research Inc.
City
Regina
State/Province
Saskatchewan
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Hospital Base Osorno
City
Osorno
Country
Chile
Facility Name
Centro de estudios cardiologicas y de Medicine Interna Ltda (Centre for Cardiology and Internal Medicine Studies)
City
Temuco
Country
Chile
Facility Name
Unidad de Investigación en Epidemiología Clínica Hospital General Regional No. 1, IMSS
City
Mexico City
Country
Mexico
Facility Name
Middlemore Clinical Trials
City
Auckland
Country
New Zealand
Facility Name
University of Auckland
City
Auckland
Country
New Zealand
Facility Name
Christchurch Heart Institute / University of Otago
City
Christchurch
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35381194
Citation
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. Erratum In: Lancet. 2022 Oct 8;400(10359):1194.
Results Reference
derived
PubMed Identifier
30205241
Citation
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.
Results Reference
derived
Links:
URL
https://www.sodiumhftrial.com/
Description
SODIUM-HF Webpage

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

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