Study of Dietary Intervention Under 100 MMOL in Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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moderate-sodium diet

sodium (100 mmol or 2300 mg daily; Usual Care)

Group Type NO_INTERVENTION

No interventions assigned to this group

low-sodium diet

(1500 mg daily)

Group Type EXPERIMENTAL

low-sodium diet (1500 mg daily)

Intervention Type OTHER

Interventions

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low-sodium diet (1500 mg daily)

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No