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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01480401
First received: November 23, 2011
Last updated: October 10, 2014
Last verified: July 2014

November 23, 2011
October 10, 2014
March 2012
March 2017   (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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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.
 
Recruiting
1000
Not Provided
March 2017   (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
July 2014

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