## Protocol Section
### Identification Module
**NCT ID:** NCT02012179

**Acronym:** SODIUM-HF

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

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

#### Organization Study ID Info
**ID:** MOP130275
#### Organization
**Class:** OTHER
**Full Name:** University of Alberta
### Status Module
#### Completion Date
**Date:** 2023-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-01-31

**Type:** ACTUAL

**Last Update Submit Date:** 2023-01-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-09

**Type:** ACTUAL

#### Start Date
**Date:** 2014-03-24

**Type:** ACTUAL

**Status Verified Date:** 2023-01

#### Study First Post Date
**Date:** 2013-12-16
**Type:** ESTIMATED
**Study First Submit Date:** 2013-12-10
**Study First Submit QC Date:** 2013-12-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Alberta

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Heart Failure

**Keywords:**

- Diet

- Dietary sodium reduction

- Salt restriction

- Nutrition

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 806

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Low sodium diet

**Label:** Low sodium diet

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** Usual Care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Low sodium diet

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

**Name:** Low sodium diet

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits

**Measure:** Composite Clinical Outcomes

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** Change in exercise capacity as measured by the 6-minute walk test (6MWT)

**Measure:** Exercise capacity

**Time Frame:** 12 months

**Description:** Change in NYHA class treated as a categorical variable

**Measure:** NYHA functional class

**Time Frame:** 12 months

**Description:** Change in quality of life assessed by the KCCQ

**Measure:** Quality of life (KCCQ)

**Time Frame:** 12 months

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chermside

**Country:** Australia

**Facility:** The Prince Charles Hospital

**Location 2:**

**City:** Darlinghurst

**Country:** Australia

**Facility:** St. Vincent's Hospital Sydney

**Location 3:**

**City:** Herston

**Country:** Australia

**Facility:** Metro North Hospital and Health Service

**Location 4:**

**City:** Calgary

**Country:** Canada

**Facility:** University of Calgary / Foothills Medical Centre

**State:** Alberta

**Location 5:**

**City:** Camrose

**Country:** Canada

**Facility:** St. Mary's Hospital

**State:** Alberta

**Location 6:**

**City:** Edmonton

**Country:** Canada

**Facility:** University of Alberta Hospital

**State:** Alberta

**Location 7:**

**City:** Red Deer

**Country:** Canada

**Facility:** Red Deer Regional Hospital

**State:** Alberta

**Location 8:**

**City:** Delta

**Country:** Canada

**Facility:** Private Cardiology Practice

**State:** British Columbia

**Location 9:**

**City:** Vancouver

**Country:** Canada

**Facility:** St. Paul's Hospital

**State:** British Columbia

**Location 10:**

**City:** Vancouver

**Country:** Canada

**Facility:** Vancouver General Hospital

**State:** British Columbia

**Location 11:**

**City:** Winnipeg

**Country:** Canada

**Facility:** St. Boniface Hospital

**State:** Manitoba

**Location 12:**

**City:** Halifax

**Country:** Canada

**Facility:** Queen Elizabeth II Health Sciences Centre

**State:** Nova Scotia

**Location 13:**

**City:** Brampton

**Country:** Canada

**Facility:** Brampton Research Associates

**State:** Ontario

**Location 14:**

**City:** Hamilton

**Country:** Canada

**Facility:** Hamilton Health Sciences

**State:** Ontario

**Location 15:**

**City:** Newmarket

**Country:** Canada

**Facility:** Southlake Regional Health Centre

**State:** Ontario

**Location 16:**

**City:** Thunder Bay

**Country:** Canada

**Facility:** Curans Heart Centre

**State:** Ontario

**Location 17:**

**City:** Toronto

**Country:** Canada

**Facility:** St. Michael's Hospital

**State:** Ontario

**Location 18:**

**City:** Toronto

**Country:** Canada

**Facility:** Toronto General Hospital

**State:** Ontario

**Location 19:**

**City:** Regina

**Country:** Canada

**Facility:** Prairie Vascular Research Inc.

**State:** Saskatchewan

**Location 20:**

**City:** Saskatoon

**Country:** Canada

**Facility:** Royal University Hospital

**State:** Saskatchewan

**Location 21:**

**City:** Osorno

**Country:** Chile

**Facility:** Hospital Base Osorno

**Location 22:**

**City:** Temuco

**Country:** Chile

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

**Location 23:**

**City:** Mexico City

**Country:** Mexico

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

**Location 24:**

**City:** Auckland

**Country:** New Zealand

**Facility:** Middlemore Clinical Trials

**Location 25:**

**City:** Auckland

**Country:** New Zealand

**Facility:** University of Auckland

**Location 26:**

**City:** Christchurch

**Country:** New Zealand

**Facility:** Christchurch Heart Institute / University of Otago

#### Overall Officials

**Official 1:**

**Affiliation:** University of Alberta

**Name:** Justin Ezekowitz, MBBCh

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 35381194

**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.

**PMID:** 30205241

#### See Also Links

**Label:** SODIUM-HF Webpage

**URL:** https://www.sodiumhftrial.com/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Misc Info Module

- Version Holder: 2024-05-24
