Back to resultsEstimated Echocardiographic Pulmonary Capillary Wedge Pressure in Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
normal sodium diet
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring sodium ,diuretics, PCWP
Eligibility Criteria
Inclusion Criteria:
- compensated HF patients
Exclusion Criteria:
- decompensated HF patients
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
normal sodium diet (120 mmol/die)
Arm Description
active comparator: low sodium diet (80 mmol/die)
Outcomes
Primary Outcome Measures
number of hospital readmitted patients
every six months we measure the PCWP by echocardiography
Secondary Outcome Measures
number of death
Full Information
NCT ID
NCT01738659
First Posted
October 23, 2012
Last Updated
November 27, 2012
Sponsor
University of Palermo
Collaborators
Ospedale G. F. Ingrassia
1. Study Identification
Unique Protocol Identification Number
NCT01738659
Brief Title
Estimated Echocardiographic Pulmonary Capillary Wedge Pressure in Heart Failure
Official Title
Moderate Versus Low Sodium Diet Intake Effects on Estimated Echocardiographic Pulmonary Capillary Wedge Pressure During 12 Months of Follow up in Compensated Heart Failure Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Palermo
Collaborators
Ospedale G. F. Ingrassia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
sodium ,diuretics, PCWP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
normal sodium diet (120 mmol/die)
Arm Type
Experimental
Arm Description
active comparator: low sodium diet (80 mmol/die)
Intervention Type
Dietary Supplement
Intervention Name(s)
normal sodium diet
Intervention Description
normal sodium diet (120 mmol/daily) for 1 year
Primary Outcome Measure Information:
Title
number of hospital readmitted patients
Description
every six months we measure the PCWP by echocardiography
Time Frame
1 year
Secondary Outcome Measure Information:
Title
number of death
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
compensated HF patients
Exclusion Criteria:
decompensated HF patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
pietro di pasquale, MD
Organizational Affiliation
G.F. Ingrassia Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Estimated Echocardiographic Pulmonary Capillary Wedge Pressure in Heart Failure
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