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Estimated Echocardiographic Pulmonary Capillary Wedge Pressure in Heart Failure

NCT ID: NCT01738659

Last Updated: 2012-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-09-30

Brief Summary

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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

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

Conditions

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Heart Failure

Keywords

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sodium ,diuretics, PCWP

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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normal sodium diet (120 mmol/die)

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

Group Type EXPERIMENTAL

normal sodium diet

Intervention Type DIETARY_SUPPLEMENT

normal sodium diet (120 mmol/daily) for 1 year

Interventions

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normal sodium diet

normal sodium diet (120 mmol/daily) for 1 year

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* compensated HF patients

Exclusion Criteria

* decompensated HF patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale G. F. Ingrassia

OTHER

Sponsor Role collaborator

University of Palermo

OTHER

Sponsor Role lead

Responsible Party

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Gaspare Parrinello

Associate Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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pietro di pasquale, MD

Role: PRINCIPAL_INVESTIGATOR

G.F. Ingrassia Hospital

Other Identifiers

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UNIPA

Identifier Type: -

Identifier Source: org_study_id