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

Phase 3CompletedNCT02012179

University of Alberta806 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

806

Conditions

Heart Failure

Interventions

Low sodium dietOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (26)

The Prince Charles Hospital

Chermside, Australia

Outcomes

Primary Outcomes

Composite Clinical Outcomes

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

Time frame: 12 months

Secondary Outcomes

Exercise capacity

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

Time frame: 12 months

NYHA functional class

Change in NYHA class treated as a categorical variable

Time frame: 12 months

Quality of life (KCCQ)

Change in quality of life assessed by the KCCQ

Time frame: 12 months

Data from ClinicalTrials.gov

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