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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2011 by Hillel Yaffe Medical Center
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01315223
First received: March 13, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  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.


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: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved clinical outcome for CHF patients [ Time Frame: Five years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: March 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: March 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suffering from CHF, NYHA II-IV class

Exclusion Criteria:

  • Patients with additional disease with life-expectancy of less than 2 years
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315223

Locations
Israel
Hillel Yaffe Medical Center Not yet 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

No publications provided

Responsible Party: Dr. Michael Shochat, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01315223     History of Changes
Other Study ID Numbers: 0010-11-HYMC
Study First Received: March 13, 2011
Last Updated: March 13, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 22, 2014