NCT02012179

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
806

participants targeted

Target at P75+ for phase_3 heart-failure

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_3 heart-failure

Geographic Reach
5 countries

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

March 24, 2014

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

8.4 years

First QC Date

December 10, 2013

Last Update Submit

January 30, 2023

Conditions

Heart Failure

Keywords

DietDietary sodium reductionSalt restrictionNutrition

Outcome Measures

Primary Outcomes (1)

  • Composite Clinical Outcomes

    All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits

    12 months

Secondary Outcomes (3)

  • Exercise capacity

    12 months

  • NYHA functional class

    12 months

  • Quality of life (KCCQ)

    12 months

Study Arms (2)

Low sodium diet

EXPERIMENTAL

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

Other: Low sodium diet

Usual Care

NO INTERVENTION

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

Interventions

Low sodium dietOTHER

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

Low sodium diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

The Prince Charles Hospital

Chermside, Australia

Location

St. Vincent's Hospital Sydney

Darlinghurst, Australia

Location

Metro North Hospital and Health Service

Herston, Australia

Location

University of Calgary / Foothills Medical Centre

Calgary, Alberta, Canada

Location

St. Mary's Hospital

Camrose, Alberta, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Red Deer Regional Hospital

Red Deer, Alberta, Canada

Location

Private Cardiology Practice

Delta, British Columbia, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Brampton Research Associates

Brampton, Ontario, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Location

Curans Heart Centre

Thunder Bay, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Toronto General Hospital

Toronto, Ontario, Canada

Location

Prairie Vascular Research Inc.

Regina, Saskatchewan, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Location

Hospital Base Osorno

Osorno, Chile

Location

Centro de estudios cardiologicas y de Medicine Interna Ltda (Centre for Cardiology and Internal Medicine Studies)

Temuco, Chile

Location

Unidad de Investigación en Epidemiología Clínica Hospital General Regional No. 1, IMSS

Mexico City, Mexico

Location

Middlemore Clinical Trials

Auckland, New Zealand

Location

University of Auckland

Auckland, New Zealand

Location

Christchurch Heart Institute / University of Otago

Christchurch, New Zealand

Location

Related Publications (2)

  • 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.

    PMID: 35381194DERIVED

  • 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.

    PMID: 30205241DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Justin Ezekowitz, MBBCh

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 16, 2013

Study Start

March 24, 2014

Primary Completion

September 1, 2022

Study Completion

January 1, 2023

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(3)NZ(3)CA(17)CL(2)ME(1)