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

U

University of Alberta

Status

Completed

Conditions

Heart Failure

Treatments

Other: low-sodium diet (1500 mg daily)

Study type

Interventional

Funder types

Other

Identifiers

NCT01480401
82-SH-01

Details and patient eligibility

About

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

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

38 participants in 2 patient groups

low-sodium diet
Experimental group
Description:
(1500 mg daily)
Treatment:
Other: low-sodium diet (1500 mg daily)
moderate-sodium diet
No Intervention group
Description:
sodium (100 mmol or 2300 mg daily; Usual Care)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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