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Completed

NCT Number: NCT02012179

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Prince Charles Hospital, Chermside, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low sodium diet

Other

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

Primary outcomes

  1. Composite Clinical Outcomes

    Time frame: 12 months

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

Secondary outcomes

  1. Exercise capacity

    Time frame: 12 months

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

  2. NYHA functional class

    Time frame: 12 months

    Change in NYHA class treated as a categorical variable

  3. Quality of life (KCCQ)

    Time frame: 12 months

    Change in quality of life assessed by the KCCQ

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Acronym: SODIUM-HF

Important dates

Study start
2014
Primary completion
2022
Study completion
2023
First posted
Dec 16, 2013
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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