Estimated Echocardiographic Pulmonary Capillary Wedge Pre... | NCT01738659

Studies
Estimated Echocardiographic Pulmonary Capillary Wedge Pressure in Heart Failure

NCT01738659

Sponsor

University of Palermo

Status

Completed

Last Update Posted

Nov 30, 2012Estimated

Enrollment

143Actual

Phase

Phase 4

Conditions

Heart Failure

Interventions

normal sodium diet

Countries

Not provided

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

Nov 2012

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

Oct 2008

Primary Completion Date

Dec 2010Actual

Completion Date

Sep 2012Actual

First Submitted Date

Oct 23, 2012

First Submission Date that Met QC Criteria

Nov 27, 2012

First Posted Date

Nov 30, 2012Estimated

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 27, 2012

Last Update Posted Date

Nov 30, 2012Estimated

Name	Class
Ospedale G. F. Ingrassia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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 aim of the study was to verify the effects of moderate versus low sodium intake on pulmonary capillary wedge pressure (PCWP), determined by Doppler echocardiography and tissue Doppler imaging in patients suffering from compensated heart failure.

Detailed Description

the study outcome is hospital readmission and mortality after 12 months of two different sodium diet.

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

143Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
normal sodium diet (120 mmol/die)	Experimental	active comparator: low sodium diet (80 mmol/die)	Dietary Supplement: normal sodium diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
normal sodium diet	Dietary Supplement	normal sodium diet (120 mmol/daily) for 1 year	normal sodium diet (120 mmol/die)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of hospital readmitted patients	every six months we measure the PCWP by echocardiography	1 year

Secondary Outcomes

Measure	Description	Time Frame
number of death		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

compensated HF patients

Exclusion Criteria:

decompensated HF patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
pietro di pasquale, MD	G.F. Ingrassia Hospital	Principal Investigator

Locations

Not provided

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