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Clinical Trials/NCT01738659
NCT01738659CompletedPhase 4

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.

University of Palermo0 sites143 target enrollmentStarted: October 1, 2008Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
143
Primary Endpoint
number of hospital readmitted patients
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •compensated HF patients

Exclusion Criteria

  • •decompensated HF patients

Arms & Interventions

normal sodium diet (120 mmol/die)

Experimental

active comparator: low sodium diet (80 mmol/die)

Intervention: normal sodium diet (Dietary Supplement)

Outcomes

Primary Outcomes

number of hospital readmitted patients

Time Frame: 1 year

every six months we measure the PCWP by echocardiography

Secondary Outcomes

  • number of death(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gaspare Parrinello

Associate Professor of Internal Medicine

University of Palermo

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