NCT01738659

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for phase_4 heart-failure

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_4 heart-failure

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
Last Updated

November 30, 2012

Status Verified

November 1, 2012

Enrollment Period

2.2 years

First QC Date

October 23, 2012

Last Update Submit

November 27, 2012

Conditions

Heart Failure

Keywords

sodium ,diuretics, PCWP

Outcome Measures

Primary Outcomes (1)

  • number of hospital readmitted patients

    every six months we measure the PCWP by echocardiography

    1 year

Secondary Outcomes (1)

  • number of death

    1 year

Study Arms (1)

normal sodium diet (120 mmol/die)

EXPERIMENTAL

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

Dietary Supplement: normal sodium diet

Interventions

normal sodium dietDIETARY_SUPPLEMENT

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

normal sodium diet (120 mmol/die)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • compensated HF patients

You may not qualify if:

  • decompensated HF patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • pietro di pasquale, MD

    G.F. Ingrassia Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Internal Medicine

Study Record Dates

First Submitted

October 23, 2012

First Posted

November 30, 2012

Study Start

October 1, 2008

Primary Completion

December 1, 2010

Study Completion

September 1, 2012

Last Updated

November 30, 2012

Record last verified: 2012-11