Trial record 4 of 71 for:    Open Studies | sodium AND (diet OR dietary)

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT02012179
First received: December 10, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

SODIUM-HF is a multicenter clinical trial in ambulatory patients with chronic HF to evaluate the efficacy of a low sodium containing diet on a composite clinical outcome composed of of all-cause mortality, cardiovascular hospitalizations and cardiovascular emergency department visits.

The hypothesis of this study is that patients following a low-sodium containing diet will have fewer clinical events (fewer hospital readmissions or emergency department visits, longer survival) than those on Usual Care.


Condition Intervention Phase
Heart Failure
Other: Low sodium diet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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 ]
    All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits


Secondary Outcome Measures:
  • Exercise capacity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in exercise capacity as measured by the 6-minute walk test (6MWT)

  • NYHA functional class [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in NYHA class treated as a categorical variable

  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in quality of life assessed by the KCCQ


Estimated Enrollment: 1000
Study Start Date: January 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low sodium diet
Low sodium diet (65 mmol or 1500 mg/day)
Other: Low sodium diet
Low sodium diet (65 mmol or 1500 mg/day)
No Intervention: Usual Care
General advice to limit dietary sodium as it is provided during routine clinic practice

  Eligibility

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

Inclusion Criteria:

  • Patients recruited if they are 18+ years or older, with confirmed diagnosis of HF (both reduced and preserved systolic function are eligible), NYHA class II-III, and willing to sign informed consent.

Exclusion Criteria:

Subjects will be excluded if:

  • Average dietary intake of <1500 mg/ day by a quantitative or semi-quantitative method
  • Serum sodium <130mmol/L
  • Renal failure (glomerular filtration rate <30 mL/min)
  • Hepatic failure
  • Uncontrolled thyroid disorder
  • Cardiac device (ICD or CRT) or revascularization procedure (PCI or CABG) in previous month or planned in next 3 months
  • Hospitalization due to cardiovascular causes in previous 1 month
  • Uncontrolled atrial fibrillation (resting heart rate >90 bpm)
  • Active malignancy
  • Moderate-severe dementia
  • Enrolled in another interventional research study
  • 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: NCT02012179

Contacts
Contact: Eloisa Colin, PhD sodiumhf@ualberta.ca
Contact: Justin Ezekowitz, MBBCh sodiumhf@ualberta.ca

Locations
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada
Contact: Eloisa Colin, PhD       sodiumhf@ualberta.ca   
Principal Investigator: Justin Ezekowitz, MBBCh         
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada
Contact       sodiumhf@ualberta.ca   
Principal Investigator: Mustafa Toma, MD         
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Justin Ezekowitz, MBBCh University of Alberta
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02012179     History of Changes
Other Study ID Numbers: MOP130275
Study First Received: December 10, 2013
Last Updated: April 14, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Alberta:
Diet
Dietary sodium reduction
Salt restriction
Nutrition

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014