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Completed

NCT Number: NCT01480401

Study of Dietary Intervention Under 100 MMOL in Heart Failure

This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients.

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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

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients will be recruited from each research center if they are 18 years or older, with confirmed diagnosis of Heart Failure (including both those with a reduced and preserved systolic function), NYHA II-IV, and willing to sign informed consent.

Exclusion criteria

  • Subjects will be excluded if they have severe hyponatremia (serum sodium <130 mmol/L)
  • Renal failure (a glomerular filtration rate < 30 mL/min)
  • Uncontrolled thyroid disorders
  • Hepatic failure
  • Implantable cardiac device (ICD or CRT) or myocardial revascularization procedures (coronary angioplasty and/or surgical revascularization) in the previous 3 months
  • Uncontrolled atrial fibrillation or recurrent ventricular arrhythmias
  • Malignancy, or with moderate-severe dementia.
  • 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 (1500 mg daily)

Other

Primary outcomes

  1. composite clinical outcomes

    Time frame: 12 months

    (cardiovascular hospitalizations, emergency department visits due acute decompensated HF, and all-cause mortality) in patients with stable HF

Secondary outcomes

  1. symptoms and quality of life

    Time frame: 12 months

    improves symptoms and quality of life for patients with stable HF

  2. reduces natriuretic peptide levels

    Time frame: 12 months

    reduces natriuretic peptide levels

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
2012
Primary completion
2014
Study completion
2014
First posted
Nov 28, 2011
Registry last updated
Jun 9, 2022

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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