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

This study is currently recruiting participants.
Verified July 2016 by Hillel Yaffe Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01315223
First Posted: March 15, 2011
Last Update Posted: July 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
  Purpose

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


Condition Intervention Phase
Chronic Congestive Heart Failure Other: Lung impedence-guided treatment Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Reduction of hospitalization for acute heart failure [ Time Frame: Five years ]

Secondary Outcome Measures:
  • Improved clinical outcome for CHF patients [ Time Frame: Five years ]

Estimated Enrollment: 300
Study Start Date: March 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional treatment CHF patients
One hundred and fifty patients with CHF will be treated according to current guidelines (conventional treatment).
Experimental: Lung impedence-guided treatment Other: Lung impedence-guided treatment
One hundred fifty patients with CHF will be treated according to common practice and values of lung impedance

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315223


Locations
Israel
Hillel Yaffe Medical Center Recruiting
Hadera, Israel, 38100
Contact: Michael Shochat, MD    972-4-630-4484    shochat1@yahoo.com   
Principal Investigator: Michael Shochat, MD, PhD         
Sub-Investigator: Avraham Shotan, MD         
Sub-Investigator: Mark Kazatsker, MD         
Sub-Investigator: Yaniv Levy, MD         
Sub-Investigator: Simcha Meisel, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01315223     History of Changes
Other Study ID Numbers: 0010-11-HYMC
First Submitted: March 13, 2011
First Posted: March 15, 2011
Last Update Posted: July 21, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases