Sodium Management in Acute and Chronic Heart Failure

Sodium Management in Acute and Chronic Phases in Patients With New York Heart Association Class III (Class C) Heart Failure. Short and Long Term Findings.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01156337

Acronym

SMAC-HF

Enrollment

Unknown

Registered

2010-07-02

Start date

2000-09-30

Completion date

2010-03-31

Last updated

2011-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure III NYHA class, Furosemide, Sodium, water restriction, decompensated heart failure, Hypertonic saline solution, Moderate sodium restriction

Brief summary

The study was aimed to verify the effects of Hypertonic saline solution (HSS) and a moderate sodium (Na) restriction plus high furosemide dose in the short term (hospitalization time) and a moderate Na restriction in the long term on readmissions and mortality in patients in III NYHA class.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Decompensated HF due to ischemic or nonischemic cardiomyopathy, * \>18 years of age, * HF according to Framingham criteria * NYHA functional class III * EF \<40%, * Serum creatinine \<2,5 mg/dL * BUN \<60 mg/dL,

Exclusion criteria

* NYHA class \> III or \< III, * Cerebral vascular disease, * Dementia, * Cancer, * Uncompensated diabetes, * Severe hepatic disease * Patients requiring pacemaker * Previous RCT implantation * Alcoholic habit

Design outcomes

Primary

Measure	Time frame
readmission for HF worsening	—

Secondary

Measure	Time frame
mortality	—

Countries

Italy

Outcome results