Study of Dietary Intervention Under 100 MMOL in Heart Failure

Heart Failure Clinical Trial

— SODIUM-HF  

Official title:

The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480401
• Other study ID #: 82-SH-01
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• low-sodium diet (1500 mg daily)

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite clinical outcomes	(cardiovascular hospitalizations, emergency department visits due acute decompensated HF, and all-cause mortality) in patients with stable HF	12 months
Secondary	symptoms and quality of life	improves symptoms and quality of life for patients with stable HF	12 months
Secondary	reduces natriuretic peptide levels	reduces natriuretic peptide levels	12 months

External Links

•   doi:10.1016/j.ahj.2014.11.013