NCT00382746

Brief Summary

CHF patients will be monitored using EarlySense ES-16 device and will simultaneously fill diaries and log their weight daily. The data collected and analyzed by the ES-16 device will be correlated with the CHF status data.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

September 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

July 19, 2016

Status Verified

April 1, 2008

Enrollment Period

1.1 years

First QC Date

September 28, 2006

Last Update Submit

July 17, 2016

Conditions

Congestive Heart Failure

Keywords

CongestiveHeartFailureCHF

Outcome Measures

Primary Outcomes (1)

  • CHF

    1 month

Interventions

EarlySense monitoring deviceDEVICE

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 45 years old
  • CHF class II or III with LVEF\<40%
  • Hospitalized at least once for CHF deterioration over previous 12 month period
  • Able and willing to cooperate with this trial for at least a 3 month period
  • Home close to participating center

You may not qualify if:

  • Recent (within 3 month) admission to ICU or CC-ICU due to severe CHF episode requiring artificial ventilation
  • Asthma or COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Shmuel Rispler, M.D.

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

October 1, 2006

Primary Completion

November 1, 2007

Study Completion

March 1, 2008

Last Updated

July 19, 2016

Record last verified: 2008-04

Locations

IL(1)