NCT01156337

Brief Summary

The study was aimed to verify the effects of Hypertonic saline solution (HSS) and a moderate sodium (Na) restriction plus high furosemide dose in the short term (hospitalization time) and a moderate Na restriction in the long term on readmissions and mortality in patients in III NYHA class.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

September 1, 2000

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
Last Updated

November 21, 2011

Status Verified

August 1, 2007

Enrollment Period

9.5 years

First QC Date

July 1, 2010

Last Update Submit

November 18, 2011

Conditions

Heart Failure

Keywords

Heart failure III NYHA classFurosemideSodiumwater restrictiondecompensated heart failureHypertonic saline solutionModerate sodium restriction

Outcome Measures

Primary Outcomes (1)

  • readmission for HF worsening

Secondary Outcomes (1)

  • mortality

Study Arms (2)

low sodium diet 80 mmol/day

moderate sodium intake 120 mmol/day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in III NYHA class HF

You may qualify if:

  • Decompensated HF due to ischemic or nonischemic cardiomyopathy,
  • \>18 years of age,
  • HF according to Framingham criteria
  • NYHA functional class III
  • EF \<40%,
  • Serum creatinine \<2,5 mg/dL
  • BUN \<60 mg/dL,

You may not qualify if:

  • NYHA class \> III or \< III,
  • Cerebral vascular disease,
  • Dementia,
  • Cancer,
  • Uncompensated diabetes,
  • Severe hepatic disease
  • Patients requiring pacemaker
  • Previous RCT implantation
  • Alcoholic habit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GF Ingrassia Hospital

Palermo, 90100, Italy

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2010

First Posted

July 2, 2010

Study Start

September 1, 2000

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

November 21, 2011

Record last verified: 2007-08

Locations

IT(1)