NCT00280254

Brief Summary

The purpose of this study was to compare two strategies in the treatment of outpatients with heart failure. We hypothesized that an individualized treatment strategy based on the availability of hemodynamic data from non-invasive testing would be feasible and significantly reduce morbidity compared to the conventional clinically oriented treatment of heart failure outpatients.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for phase_2 heart-failure

Timeline
Completed

Started Nov 1999

Longer than P75 for phase_2 heart-failure

Status
terminated

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

November 1, 1999

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2006

Completed
Last Updated

January 20, 2006

Status Verified

January 1, 2006

First QC Date

January 19, 2006

Last Update Submit

January 19, 2006

Conditions

Heart Failure

Keywords

Heart FailureHemodynamicsEchocardiography

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy end-point was time to the first event of combined all-cause mortality and all-cause hospitalization or emergency room visit

Secondary Outcomes (1)

  • Secondary end-points were changes in hemodynamic estimates (right atrial pressure, systolic pulmonary artery pressure and systemic vascular resistance), serum electrolytic measurement and renal function.

Interventions

Hemodynamically Oriented Echocardiography-based StrategyPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • age greater than 18 years old,
  • CHF diagnosis for more than 6 months regardless of etiology,
  • echocardiography-based left ventricular ejection fraction equal or less than 40%, and
  • prior CHF admission within three months from randomization

You may not qualify if:

  • thoracic deformity or severe chronic lung disease imposing technical limitation to perform high-quality echocardiography,
  • acute coronary syndrome in the last three months,
  • congenital heart disease,
  • moderate to severe stenotic heart valve disease or
  • end-stage renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Nadine O Clausell, MD

    Federal University of Rio Grande do Sul. Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2006

First Posted

January 20, 2006

Study Start

November 1, 1999

Study Completion

December 1, 2004

Last Updated

January 20, 2006

Record last verified: 2006-01