Sodium Management in Acute and Chronic Heart Failure | NCT01156337

Studies
Sodium Management in Acute and Chronic Heart Failure

NCT01156337

Sponsor

Ospedale G. F. Ingrassia

Status

Completed

Last Update Posted

Nov 21, 2011Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Heart Failure

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2000

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jul 1, 2010

First Submission Date that Met QC Criteria

Jul 1, 2010

First Posted Date

Jul 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2011

Last Update Posted Date

Nov 21, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Ospedale G. F. IngrassiaOTHER

Collaborators

Name	Class
University of Palermo	OTHER
University of Naples	OTHER
Buccheri La Ferla Hospital, Palermo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Measure	Description	Time Frame
readmission for HF worsening

Measure	Description	Time Frame
mortality

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients in III NYHA class HF

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GF Ingrassia Hospital		Palermo		90100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
low sodium diet 80 mmol/day
moderate sodium intake 120 mmol/day