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Clinical Trials/NCT01315223
NCT01315223
Unknown
Phase 3

Outpatient Lung Impedance-Guided Preventive Therapy in Patients With Chronic Heart Failure (CHF)

Hillel Yaffe Medical Center1 site in 1 country300 target enrollmentMarch 2011

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Chronic Congestive Heart Failure
Sponsor
Hillel Yaffe Medical Center
Enrollment
300
Locations
1
Primary Endpoint
Reduction of hospitalization for acute heart failure
Last Updated
9 years ago

Overview

Brief Summary

Patients suffering from Chronic Heart Failure (CHF) are hospitalized for acute heart failure (AHF) several times a year. Currently, we have no method for prediction of future developments of AHF. In our center we have investigated the monitoring of lung impedence as a predictor for future deterioration. It was found that a decrease in lung impedence of more than 15% from normal value predicts AHF development with sensitivity of 98%. In this study we try to prove the hypothesis that preventive treatment according to lung impedence value may prevent future hospitalizations for AHF and improve clinical outcome.

Patients recruited by year:

2011 - 50; 2012 - 25; 2013 - 35; 2014 - 30; 2015 - 50; 2016 - 5

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
June 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients suffering from CHF, NYHA II-IV class
  • LV lower than 35% to LV lower than 45%

Exclusion Criteria

  • Patients with additional disease with life-expectancy of less than 2 years

Outcomes

Primary Outcomes

Reduction of hospitalization for acute heart failure

Time Frame: Five years

Secondary Outcomes

  • Improved clinical outcome for CHF patients(Five years)

Study Sites (1)

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