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

This study is currently recruiting participants.
Verified August 2012 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01480401
First received: November 23, 2011
Last updated: August 20, 2012
Last verified: August 2012

November 23, 2011
August 20, 2012
March 2012
March 2015   (final data collection date for primary outcome measure)
composite clinical outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
(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 ] [ Designated as safety issue: No ]
    improves symptoms and quality of life for patients with stable HF
  • reduces natriuretic peptide levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    reduces natriuretic peptide levels
  • symptoms and quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    improves symptoms and quality of life for patients with stable HF
  • Serum aldosterone levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Serum aldosterone levels
  • lower dose of loop diuretics needed [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    lower dose of loop diuretics needed
  • reduces natriuretic peptide levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Heart Failure
  • Other: Low sodium diet
    (80 mmol or 1800 mg daily of sodium
  • Other: moderate sodium diet
    100 mmol or 2300 mg daily of sodium
  • Experimental: low-sodium diet
    (80 mmol or 1800 mg daily)
    Intervention: Other: Low sodium diet
  • Experimental: moderate-sodium diet
    sodium(100 mmol or 2300 mg daily)
    Intervention: Other: moderate sodium diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
760
Not Provided
March 2015   (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.
Both
18 Years and older
No
Contact: Eloisa Colin eloisa@ualberta.ca
Canada
 
NCT01480401
82-SH-01
Yes
University of Alberta
University of Alberta
Not Provided
Principal Investigator: Justin Ezekowitz, MBBCh MSc University of Alberta
University of Alberta
August 2012

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