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

University of Alberta

Status and phase

Completed

Phase 3

Conditions

Heart Failure

Treatments

Other: Low sodium diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02012179

MOP130275

Details and patient eligibility

About

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.

Enrollment

806 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.