Estimated Echocardiographic Pulmonary Capillary Wedge Pressure in Heart Failure

This study has been completed.
Sponsor:
Collaborator:
Ospedale G. F. Ingrassia
Information provided by (Responsible Party):
Gaspare Parrinello, University of Palermo
ClinicalTrials.gov Identifier:
NCT01738659
First received: October 23, 2012
Last updated: November 27, 2012
Last verified: November 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 University of Palermo:

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


Secondary Outcome Measures:
  • number of death [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • compensated HF patients

Exclusion Criteria:

  • decompensated HF patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738659

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

No publications provided

Responsible Party: Gaspare Parrinello, Associate Professor of Internal Medicine, University of Palermo
ClinicalTrials.gov Identifier: NCT01738659     History of Changes
Other Study ID Numbers: UNIPA
Study First Received: October 23, 2012
Last Updated: November 27, 2012
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014