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

History of Changes

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:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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

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 May 22, 2013

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