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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01480401
First Posted: November 28, 2011
Last Update Posted: December 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Alberta
November 23, 2011
November 28, 2011
December 19, 2014
March 2012
November 2014   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01480401 on ClinicalTrials.gov Archive Site
  • symptoms and quality of life [ Time Frame: 12 months ]
    improves symptoms and quality of life for patients with stable HF
  • reduces natriuretic peptide levels [ Time Frame: 12 months ]
    reduces natriuretic peptide levels
  • symptoms and quality of life [ Time Frame: 12 months ]
    improves symptoms and quality of life for patients with stable HF
  • Serum aldosterone levels [ Time Frame: 12 months ]
    Serum aldosterone levels
  • lower dose of loop diuretics needed [ Time Frame: 12 months ]
    lower dose of loop diuretics needed
  • reduces natriuretic peptide levels [ Time Frame: 12 months ]
    reduces natriuretic peptide levels
Not Provided
Not Provided
 
Study of Dietary Intervention Under 100 MMOL in Heart Failure
The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure
This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
Other: low-sodium diet (1500 mg daily)
  • Experimental: low-sodium diet
    (1500 mg daily)
    Intervention: Other: low-sodium diet (1500 mg daily)
  • No Intervention: moderate-sodium diet
    sodium (100 mmol or 2300 mg daily; Usual Care)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
November 2014
November 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01480401
82-SH-01
Yes
Not Provided
Not Provided
University of Alberta
University of Alberta
Not Provided
Principal Investigator: Justin Ezekowitz, MBBCh MSc University of Alberta
University of Alberta
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP