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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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


Condition Intervention Phase
Heart Failure
Other: Low sodium diet
Other: moderate sodium diet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 760
Study Start Date: March 2012
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low-sodium diet
(80 mmol or 1800 mg daily)
Other: Low sodium diet
(80 mmol or 1800 mg daily of sodium
Experimental: moderate-sodium diet
sodium(100 mmol or 2300 mg daily)
Other: moderate sodium diet
100 mmol or 2300 mg daily of sodium

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480401

Contacts
Contact: Eloisa Colin eloisa@ualberta.ca

Locations
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Justin Ezekowitz, MBBCh MSc University of Alberta
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01480401     History of Changes
Other Study ID Numbers: 82-SH-01
Study First Received: November 23, 2011
Last Updated: August 20, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Patients with stable heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014