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

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. Identifier: NCT01315223
Recruitment Status : Recruiting
First Posted : March 15, 2011
Last Update Posted : July 21, 2016
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

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

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : March 2011
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01315223

Hillel Yaffe Medical Center Recruiting
Hadera, Israel, 38100
Contact: Michael Shochat, MD    972-4-630-4484   
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

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases