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Estimated Echocardiographic Pulmonary Capillary Wedge Pressure in Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01738659
First Posted: November 30, 2012
Last Update Posted: November 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ospedale G. F. Ingrassia
Information provided by (Responsible Party):
Gaspare Parrinello, University of Palermo
  Purpose
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.

Condition Intervention Phase
Heart Failure Dietary Supplement: normal sodium diet Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Gaspare Parrinello, University of Palermo:

Primary Outcome Measures:
  • number of hospital readmitted patients [ Time Frame: 1 year ]
    every six months we measure the PCWP by echocardiography


Secondary Outcome Measures:
  • number of death [ Time Frame: 1 year ]

Enrollment: 143
Study Start Date: October 2008
Study Completion Date: September 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: normal sodium diet (120 mmol/die)
active comparator: low sodium diet (80 mmol/die)
Dietary Supplement: normal sodium diet
normal sodium diet (120 mmol/daily) for 1 year

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • compensated HF patients

Exclusion Criteria:

  • decompensated HF patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738659


Sponsors and Collaborators
University of Palermo
Ospedale G. F. Ingrassia
Investigators
Principal Investigator: pietro di pasquale, MD G.F. Ingrassia Hospital
  More Information

Responsible Party: Gaspare Parrinello, Associate Professor of Internal Medicine, University of Palermo
ClinicalTrials.gov Identifier: NCT01738659     History of Changes
Other Study ID Numbers: UNIPA
First Submitted: October 23, 2012
First Posted: November 30, 2012
Last Update Posted: November 30, 2012
Last Verified: November 2012

Keywords provided by Gaspare Parrinello, University of Palermo:
sodium ,diuretics, PCWP

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases