Study of Dietary Intervention Under 100 MMOL in Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT01480401
• Lead Sponsor: University of Alberta

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-23
• Study First Submitted QC: 2011-11-25
• Study First Posted: 2011-11-28
• Study Start: 2012-03
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
composite clinical outcomes	12 months	(cardiovascular hospitalizations, emergency department visits due acute decompensated HF, and all-cause mortality) in patients with stable HF

Secondary Outcome Measures

Name	Time	Method
reduces natriuretic peptide levels	12 months	reduces natriuretic peptide levels
symptoms and quality of life	12 months	improves symptoms and quality of life for patients with stable HF

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada